NDC 70764-201 Botanical Soothing Spf-30

Octinoxate, Octisalate, Zinc Oxide

NDC Product Code 70764-201

NDC 70764-201-52

Package Description: 1 BOTTLE in 1 BOX > 74 mL in 1 BOTTLE (70764-201-22)

NDC Product Information

Botanical Soothing Spf-30 with NDC 70764-201 is a a human over the counter drug product labeled by Control Corrective Skincare Inc. The generic name of Botanical Soothing Spf-30 is octinoxate, octisalate, 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.

Botanical Soothing Spf-30 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.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
  • SQUALANE (UNII: GW89575KF9)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VACCINIUM MYRTILLUS WHOLE (UNII: EE76EZ4QNZ)
  • ACER SACCHARUM WHOLE (UNII: KEG5092LU9)
  • CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)
  • CITRUS LIMON WHOLE (UNII: EEI224A33Y)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • CITRUS MAXIMA SEED (UNII: 083X55C543)
  • HONEY (UNII: Y9H1V576FH)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PHYTONADIONE (UNII: A034SE7857)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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: Control Corrective Skincare Inc
Labeler Code: 70764
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: 06-08-2016 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: 12-31-2021 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.

Botanical Soothing Spf-30 Product Label Images

Botanical Soothing Spf-30 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

OCTINOXATE (6.9%)OCTISALATE (3.0%)ZINC OXIDE (4.0%)

Purpose

SUNSCREEN

Use

A SOOTHING, CALMING AND HYDRATING MOISTURIZER IN ONE. ALSO HELPS TO REDUCE THE APPEARANCE OF SKIN FLUSHING, REDNESS AND VASCULAR STIMULATION. CONTAINING SPF 30 TO FIGHT THE SIGNES OF AGING. A MUST FOR THOSE SUFFERING WITH SKIN AND SUN SENSITIVITIES.

Warning

FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS.

Directions

APPLY GENEROUSLY WITH FINGERS TO ENTIRE FACE AND NECK. USE DAILY.

Other Safety Information

SUN ALERT: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISK OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

Inactive Ingredients

WATER, ALOE BARBADENSIS LEAF, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDES, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CETEARETH-20, VP/EICOSENE COPOLYMER, SQUALANE, POLYSORBATE 60, CYCLOTETRASILOXANE, PHENOXYETHANOL, BUTYROSPERMUM PARKII BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, TOCOPHERYL ACETATE, VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT, SACCHARUM OFFICINARIUM (SUGAR CANE) EXTRACT, ACER SACCHARUM EXTRACT, CITRUS AURANTIUM DULCIS FRUIT EXTRACT, CITRUS LIMON (LEMON) FRUIT EXTRACT, CITRUS GRANDIS SEED EXTRACT, HONEY EXTRACT, CITRIC ACID, PHYTONADIONE, METHYLISOTHIAZOLINONE, RED 33.

Otc - 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.

* Please review the disclaimer below.