NDC 69219-108 Extreme Protect Spf 40 All Shades

Extreme Protect Spf 40 All Shades with NDC 69219-108 is a a human over the counter drug product labeled by Science Of Skincare, Llc.. The generic name of Extreme Protect Spf 40 All Shades is zinc oxide, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Science Of Skincare, Llc.

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.

Extreme Protect Spf 40 All Shades 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.

• TITANIUM DIOXIDE 1.3 g/100g
• ZINC OXIDE 15.3 g/100g

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.

• ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
• POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)
• WATER (UNII: 059QF0KO0R)
• CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
• XANTHAN GUM (UNII: TTV12P4NEE)
• PHENOXYETHANOL (UNII: HIE492ZZ3T)
• ALOE VERA LEAF (UNII: ZY81Z83H0X)
• ISOSTEARIC ACID (UNII: X33R8U0062)
• FERRIC OXIDE RED (UNII: 1K09F3G675)
• POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
• GLYCERIN (UNII: PDC6A3C0OX)
• MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
• OLEYL ALCOHOL (UNII: 172F2WN8DV)
• EDETATE DISODIUM (UNII: 7FLD91C86K)
• DIMETHICONE 100 (UNII: RO266O364U)
• FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
• CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
• FERROSOFERRIC OXIDE (UNII: XM0M87F357)
• PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
• ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
• ASIATICOSIDE (UNII: PKO39VY215)
• ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
• MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
• TOCOPHEROL (UNII: R0ZB2556P8)
• SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
• HEXYL LAURATE (UNII: 4CG9F9W01Q)
• BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
• PENTYLENE GLYCOL (UNII: 50C1307PZG)
• POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
• ALUMINUM STEARATE (UNII: U6XF9NP8HM)
• ALUMINUM OXIDE (UNII: LMI26O6933)
• TRIDECETH-6 (UNII: 3T5PCR2H0C)
• PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
• ASIATIC ACID (UNII: 9PA5A687X5)
• MADECASSIC ACID (UNII: M7O1N24J82)
• OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
• POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
• TRIBEHENIN (UNII: 8OC9U7TQZ0)

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: Science Of Skincare, Llc.
Labeler Code: 69219
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2021 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. Values = ‘Y’ or ‘N’.

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