Label: FACE IT AQUA UV COLOR CONTROL 32800772- octinoxate, titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-772-22 - Packager: THEFACESHOP CO., 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 November 20, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Warnings
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Directions
Apply generously and evenly 15 minutes before sun exposure. (choice based on the first label draft)
Children under 6 months of age: Ask a doctor
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating. (product does not satisfy water resistance test)
1. After skincare, open the case and press the button 1 – 2 times to release the formula.2. Tap lightly onto skin using CC puff.
- Other Information
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Inactive Ingredients
WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE•
BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1
DIMETHICONE•MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•
TRIMETHYLSILOXYSILICATE•TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•
DISTEARDIMONIUM HECTORITE•MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•
METHYL METHACRYLATE CROSSPOLYMER•DIPHENYL DIMETHICONE•VP/HEXADECENE COPOLYMER•
PHENOXYETHANOL•TRIETHOXYCAPRYLYLSILANE•CERESIN•ALUMINUM HYDROXIDE•STEARIC ACID•
ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE•DISODIUM EDTA•SODIUM PCA•SODIUM HYALURONATE•
UREA•TREHALOSE•POLYQUATERNIUM-51•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES
FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA
ROOT EXTRACT•POLYPERFLUOROMETHYLISOPROPYL ETHER•OXYGEN•PEG-8•
CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN•ETHYLPARABEN•
PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•MICA (CI 77019)•
IRON OXIDES (CI 77491, CI 77492, CI 77499) - QUESTIONS
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT AQUA UV COLOR CONTROL 32800772
octinoxate, titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-772 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE .8 g in 20 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.3 g in 20 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE .2 g in 20 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-772-22 1 in 1 CARTON 11/20/2014 1 20 g in 1 CONTAINER; 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 11/20/2014 Labeler - THEFACESHOP CO., LTD. (688329416) Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193) Establishment Name Address ID/FEI Business Operations THEFACESHOP Co., Ltd. 688329416 label(51523-772)
