Label: FACE IT 32800378- octinoxate, titanium oxide and zind oxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-378-06 - 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 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.
Shake lightly 3 – 5 times before use. Dispense an
adequate amount and apply evenly to the skin. Then,
pat lightly with fingers for full absorption. Re-apply a
small amount to parts that require extra coverage and
pat with fingers.
Double cleansing is recommended as this product
adheres tightly to the skin. FACE IT One-ste p BB
Cleanser may be used for simple and easy cleansing.
- Other information
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Inactive Ingredients
CYCLOPENTASILOXANE•WATER•BUTYLENE GLYCOL•
DIMETHICONE•SD ALCOHOL 40-B•HDI/TRIMETHYLOL
HEXYLLACTONE CROSSPOLYMER•CAPRYLIC/CAPRIC
GLYCERIDES•ISOHEXADECANE•SODIUM CHLORIDE•
ALUMINUM HYDROXIDE•METHYL METHACRYLATE
CROSSPOLYMER•STEARIC ACID•PEG-10 DIMETHICONE•
1,2-HEXANEDIOL•TRIETHOXYCAPRYLYLSILANE•SILICA•
DISODIUM EDTA•ALOE BARBADENSIS LEAF EXTRACT•
PORTULACA OLERACEA EXTRACT•ADANSONIA DIGITATA
SEED EXTRACT•ALCOHOL•PHENOXYETHANOL•
METHYLPARABEN•PROPYLPARABEN•ETHYLPARABEN•
BUTYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE•
IRON OXIDES (CI 77491, CI 77492, CI 77499)
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT 32800378
octinoxate, titanium oxide and zind oxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-378 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3.65 g in 50 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 7.5 g in 50 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 2.95 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-378-06 1 in 1 CARTON 11/20/2014 1 50 mL 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(51523-378) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(51523-378)
