NDC 72414-004 Radiance Superbe Day Cream Neutral Caramel

Ensulizole, Octocrylene, Titanium Dioxide, Zinc Oxide

NDC Product Code 72414-004

NDC CODE: 72414-004

Proprietary Name: Radiance Superbe Day Cream Neutral Caramel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ensulizole, Octocrylene, Titanium Dioxide, Zinc Oxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 72414-004-15

Package Description: 15 g in 1 APPLICATOR

NDC 72414-004-50

Package Description: 50 g in 1 BOTTLE, PUMP

NDC Product Information

Radiance Superbe Day Cream Neutral Caramel with NDC 72414-004 is a a human over the counter drug product labeled by Haute Custom Beauty. The generic name of Radiance Superbe Day Cream Neutral Caramel is ensulizole, octocrylene, titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Radiance Superbe Day Cream Neutral Caramel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • PEA PROTEIN (UNII: 7Q50F46595)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CINNAMYL ALCOHOL (UNII: SS8YOP444F)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
  • SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CERAMIDE EOS (UNII: CR0J8RN66K)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • EUGENOL (UNII: 3T8H1794QW)
  • HEXYL CINNAMATE (UNII: 532UJ0Y6RI)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • PEA PROTEIN (UNII: 7Q50F46595)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CINNAMYL ALCOHOL (UNII: SS8YOP444F)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
  • SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CERAMIDE EOS (UNII: CR0J8RN66K)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • EUGENOL (UNII: 3T8H1794QW)
  • HEXYL CINNAMATE (UNII: 532UJ0Y6RI)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • PEA PROTEIN (UNII: 7Q50F46595)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CINNAMYL ALCOHOL (UNII: SS8YOP444F)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
  • SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CERAMIDE EOS (UNII: CR0J8RN66K)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • EUGENOL (UNII: 3T8H1794QW)
  • HEXYL CINNAMATE (UNII: 532UJ0Y6RI)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • PEA PROTEIN (UNII: 7Q50F46595)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CINNAMYL ALCOHOL (UNII: SS8YOP444F)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
  • SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CERAMIDE EOS (UNII: CR0J8RN66K)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • EUGENOL (UNII: 3T8H1794QW)
  • HEXYL CINNAMATE (UNII: 532UJ0Y6RI)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • PEA PROTEIN (UNII: 7Q50F46595)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CINNAMYL ALCOHOL (UNII: SS8YOP444F)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
  • SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CERAMIDE EOS (UNII: CR0J8RN66K)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • EUGENOL (UNII: 3T8H1794QW)
  • HEXYL CINNAMATE (UNII: 532UJ0Y6RI)
  • CERAMIDE AP (UNII: F1X8L2B00J)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • PEA PROTEIN (UNII: 7Q50F46595)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CINNAMYL ALCOHOL (UNII: SS8YOP444F)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
  • MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
  • SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CERAMIDE EOS (UNII: CR0J8RN66K)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • EUGENOL (UNII: 3T8H1794QW)
  • HEXYL CINNAMATE (UNII: 532UJ0Y6RI)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Haute Custom Beauty
Labeler Code: 72414
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-28-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Radiance Superbe Day Cream Neutral Caramel Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients......Sunscreen

Octocrylene 6%.........SunscreenTitanium dioxide 5%.........SunscreenZinc oxide 5%.........SunscreenEnsulizole 4%..........Sunscreen

Inactive Ingredients

AQUA (WATER), PROPANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM ACRYLATES COPOLYMER, COPERNICIA CERIFERA WAX, ORYZA SATIVA WAX, CENTELLA ASIATICA (HYDROCOTYL) LEAF EXTRACT, HYDROLIZED SILK, LECITHIN, TOCOPHERYL ACETATE, XANTHAN GUM, POLYHYDROXYSTEARIC ACID, ALUMINA, STEARIC ACID, ROYAL JELLY EXTRACT, GLYCERYL LINOLEATE, GLYCERYL LINOLENATE, PANTHENOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, PHENOXYETHANOL, GLYCERIN, CAPRYLYL GLYCOL, SODIUM HYDROXIDE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ARTEMIA EXTRACT, PLANKTON EXTRACT, ALGAE EXTRACT, PARFUM (FRAGANCE), PHYTOSTEROLS, OLEA EUROPAEA (OLIVE) FRUIT OIL, SQUALANE, HYDROLYZED PEA PROTEIN, BUTYROSPERMUM PARKII (SHEA) BUTTER, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, PHYTOSPHINGOSINE, CHOLESTEROL, SODIUM LAUROYL LACTYLATE, CARBOMER, DIISOPROPYL ADIPATE, ACRYLIC ACID/ACRYLAMIDOMETHYL PROPANE SULFONIC ACID COPOLYMER, DIMETHYLMETHOXY CHROMANOL, GLYCERYL CAPRILATE, PHOSPHOLIPIDS, CARAMEL, CI 77891, CI 77492, CI 77491 , CI 77499 , CINNAMYL ALCOHOL, EUGENOL, HEXYL CINNAMAL, LINALOOL, d-LIMONENE, CITRONELLOL, BENZYL SALICYLATE.

Uses

Helps prevent sunburn * higher SPF gives more sunburn protection * if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irratation develos and lasts. You may report effects to FDA at 1-800-FDA-1088. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For suncreen use: *apply liberally 15 minutes before sun exposure and as needed * reapply at least every 2 hours and as needed or after towel drying, swimming, or perspiring. *. use water resistant sunscreen if swimming or sweating * Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including: * limit time in th esun, especially from 10 a.m. - 2 p.m.* wear long-sleeve shirts, pants, hats and sunglasses*children under 6 months of age: Ask a doctor

Other Information

Other information * protect this product from excessive heat and direct sun. * Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Description

RADIANCE SUPERBE DAY CREAM BROAD SPECTRUM SPF 35OIL-FREE SUNSCREENA latest generation Triple Age Management Sunscreen with an immediate ultra-sheer complexion perfecting finish availalbe in 6 ultra-sheer shades + translucent, leaving skin with a radiant, healthy glow. Oil free, for all skin types, including sensitive skin. Haute Custom Beauty SLUPasseig de Gracia 4108047 Barcelona Haute Custom Beauty INC Austin, TX 78703 USAPRODUCT OF SPAINwww.hautecustombeauty.comAirplane image OKGluten FreeNo: parabens, sulphates, mineral oil, silicons, phthalates, PEGS, methysilothazzolinone, petroleum derivatives

* Please review the disclaimer below.