Label: FACE IT POWER PERFECTION 32800843- octinoxate, titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-843-27 - 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.
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 t o 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.
Dispense an adequate amount on a sponge or
fingertips and apply evenly to your face.
Tap gently to allow complete absorption. - Other Information
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Inactive Ingredients
WATER•CYCLOPENTASILOXANE•PHENYL TRIMETHICONE•
CYCLOHEXASILOXANE•BUTYLENE GLYCOL•
ISODODECANE•CETYL PEG/PPG-10/1 DIMETHICONE•
NIACINAMIDE•METHYLPROPANEDIOL•METHYL
METHACRYLATE CROSSPOLYMER•BUTYLENE GLYCOL•
DICAPRYLATE/DICAPRATE•POLYGLYCERYL-4
ISOSTEARATE•SODIUM CHLORIDE•DISTEARDIMONIUM
HECTORITE•SORBITAN ISOSTEARATE•HYDROGENATED
POLY(C6-14 OLEFIN)•HYDROGENATED POLYISOBUTENE•
OZOKERITE•PHENOXYETHANOL•DIMETHICONE•
HEXYL LAURATE•DIMETHICONE/VINYL DIMETHICONE
CROSSPOLYMER•ALUMINUM HYDROXIDE•BEESWAX•
TRIETHOXYCAPRYLYLSILANE•STEARIC ACID•
FRAGRANCE(PARFUM)•ETHYLHEXYLGLYCERIN•
PROPYLENE CARBONATE•PRUNUS AMYGDALUS DULCIS
(SWEET ALMOND) OIL•ADENOSINE•DISODIUM EDTA•
PLUKENETIA VOLUBILIS SEED OIL•ALUMINA•XANTHAN
GUM•CAPRYLIC/CAPRIC GLYCERIDES•RASPBERRY SEED
OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL
ESTERS•ASCORBIC ACID•HYDROLYZED EXTENSIN•
SODIUM HYALURONATE•SCHINUS TEREBINTHIFOLIUS
SEED EXTRACT•RETINOL•LINOLEIC ACID•CERAMIDE 3•
TOCOPHEROL•PORTULACA OLERACEA EXTRACT•
GYNOSTEMMA PENTAPHYLLUM LEAF/STEM EXTRACT•
CALCIUM ALUMINUM BOROSILICATE•
BETA-GLUCAN•IRON OXIDES (CI 77491,CI 77492, CI 7749) - QUESTIONS
- Distributed by:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT POWER PERFECTION 32800843
octinoxate, titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-843 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.2 g in 40 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 40 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.9 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:51523-843-27 1 in 1 CARTON 11/20/2014 1 40 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 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(51523-843)
