Label: FACE IT AURA COLOR CONTROL 32800658- octinoxate, titanium oxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-658-15 - 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
- Uses
- Warnings
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Directions
Apply generously and evenly 15 minutes before sun exposure.
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.
Pump 1 – 2 times to release the formula. After skincare, apply evenly onto face in a light tapping
motion using the enclosed CC puff. Do the same for the touch-ups.
- 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•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•
ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT•OXYGEN•MALTITOL•
SORBITANISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE•
TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE•
MAGNESIUMSULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•DIPHENYL DIMETHICONE•
VP/HEXADECENECOPOLYMER•METHYL METHACRYLATE CROSSPOLYMER•TRIETHOXYCAPRYLYLSILANE•
CERESIN•ALUMINUMHYDROXIDE•STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE•
SODIUM PCA•SODIUMHYALURONATE•UREA•TREHALOSE•POLYQUATERNIUM-51•
POLYPERFLUOROMETHYLISOPROPYL ETHER•PEG-8•CARBOMER•DISODIUM EDTA•
PHENOXYETHANOL•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN•
ETHYLPARABEN•PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•
MICA (CI 77019)•IRON OXIDES (CI 77491, CI 77492, CI 77499)
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT AURA COLOR CONTROL 32800658
octinoxate, titanium oxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-658 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:51523-658-15 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(51523-658)
