Label: FACE IT SMART COLOR CONTROL 32800677- ensulizole, titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-677-21 - 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.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- 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 hoursUse a water-resistant sunscreen if swimming or sweating.At the final stage of skincare, smooth out the CC cream onto entire face following the skin texture.
Recommended to pump only once per application to release an adequate amount.
Pump gently to avoid any spatter.
- Other Information
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Inactive Ingredients
WATER•CYCLOPENTASILOXANE•BUTYLENE GLYCOL•CETYL ETHYLHEXANOATE•METHYL TRIMETHICONE•
DIPHENYLSILOXY PHENYL TRIMETHICONE•NIACINAMIDE•DIMETHICONE•SILICA•TROMETHAMINE•
CYCLOHEXASILOXANE•PEG-10 DIMETHICONE•DISTEARDIMONIUM HECTORITE•POLYMETHYL METHACRYLATE•
SORBITAN ISOSTEARATE•DIMETHICONE CROSSPOLYMER•HEXYL LAURATE•METHYL METHACRYLATE CROSSPOLYMER•
DIMETHICONE/PEG-10/15 CROSSPOLYMER•CAPRYLIC/CAPRIC GLYCERIDES•MAGNESIUM SULFATE•ALUMINUM
HYDROXIDE•STEARIC ACID•MICA•ETHYLHEXYL TRIAZONE•METHYLPARABEN•PROPYLENE CARBONATE•
TRIETHOXYCAPRYLYLSILANE•DISTEARYLDIMONIUM CHLORIDE•POLYESTER-1•SILICA DIMETHYL SILYLATE•
ETHYLPARABEN•DIMETHICONOL•ADENOSINE•DIPROPYLENE GLYCOL•SODIUM CITRATE•ALUMINA•
POLYPERFLUOROMETHYLISOPROPYL ETHER•TOCOPHEROL•CITRUS AURANTIUM DULCIS
(ORANGE) FRUIT EXTRACT•CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT•FRAGRANCE•IRON
OXIDES (CI 77491, CI 77492, CI 77499) - QUESTIONS
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INGREDIENTS AND APPEARANCE
FACE IT SMART COLOR CONTROL 32800677
ensulizole, titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-677 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.1 g in 40 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.6 g in 40 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.2 g in 40 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-677-21 1 in 1 CARTON 11/20/2014 1 40 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(51523-677)
