Label: COTZ FACE PRIME AND PROTECT SPF 40 (TINTED)- titanium dioxide, zinc oxide cream
- NDC Code(s): 58892-354-45
- Packager: Fallien Cosmeceuticals, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 21, 2021
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- Official Label (Printer Friendly)
- Active Ingredients:
- Purpose:
-
Uses:
Helps prevent sunburn. 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:
-
Directions:
- Apply liberally 15 minutes before sun exposure.
Reapply:
- -
- After 80 minutes of swimming or sweating
- -
- Immediately after towel drying
- -
- At least every two hours
- Children under 6 months: Ask a doctor
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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 SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Other Information:
- Principal Display Panel - 42.5 g Carton Label
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INGREDIENTS AND APPEARANCE
COTZ FACE PRIME AND PROTECT SPF 40 (TINTED)
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-354 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 80 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 38 mg in 1 g Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone 20 (UNII: H8YMB5QY0D) Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Dimethiconol (2000 CST) (UNII: T74O12AN6Y) Brown Iron Oxide (UNII: 1N032N7MFO) Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX) Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N) PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-354-45 1 in 1 CARTON 05/01/2021 1 42.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/26/2012 Labeler - Fallien Cosmeceuticals, LTD (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-354) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(58892-354) , PACK(58892-354)