Label: THEFACESHOP CC CUSHION NATURAL BEIGE OIL-FREE SPF 50- ensulizole, titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-051-03 - 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 January 1, 2021
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
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- Apply liberally 15 minutes before sun exposure and as needed.
- Reapply as needed or after towel drying, swimming, or sweating.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. to 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENTS
CYCLOPENTASILOXANE, WATER, TRIETHYLHEXANOIN, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, DIPROPYLENE GLYCOL, TROMETHAMINE, BIOSACCHARIDE GUM-1, 1,2-HEXANEDIOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, SORBITAN SESQUIISOSTEARATE, ZINC STEARATE, DISTEARDIMONIUM HECTORITE, CITRUS UNSHIU PEEL EXTRACT, ALBIZIA JULIBRISSIN BARK EXTRACT, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, ALUMINUM HYDROXIDE, PALMITOYL PROLINE, BUTYLENE GLYCOL, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITIC ACID, SILICA, CALCIUM CARBONATE, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77491, CI 77492, CI 77499)
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL CC OIL-FREE CUSHION BROAD SPECTRUM SPF 50 THEFACESHOP Net Wt. 0.52 oz | 15g
- THEFACESHOP CC OIL-FREE CUSHION V203 NATURAL BEIGE [Broad Spectrum SPF 50] Net Wt. 0.52 oz | 15 g.
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INGREDIENTS AND APPEARANCE
THEFACESHOP CC CUSHION NATURAL BEIGE OIL-FREE SPF 50
ensulizole, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 0.405 g in 15 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.819 g in 15 g Inactive Ingredients Ingredient Name Strength TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF) CALCIUM CARBONATE (UNII: H0G9379FGK) ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) METHYL METHACRYLATE (UNII: 196OC77688) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) ZINC STEARATE (UNII: H92E6QA4FV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPROPYLENE GLYCOL (UNII: E107L85C40) NIACINAMIDE (UNII: 25X51I8RD4) TROMETHAMINE (UNII: 023C2WHX2V) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PALMITOYL PROLINE (UNII: I49727TDYF) TANGERINE PEEL (UNII: JU3D414057) ADENOSINE (UNII: K72T3FS567) MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48) PHENOXYETHANOL (UNII: HIE492ZZ3T) PALMITIC ACID (UNII: 2V16EO95H1) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-051-03 2 in 1 BOX 01/01/2018 1 15 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 01/01/2018 Labeler - THEFACESHOP Co., Ltd. (688329416) Establishment Name Address ID/FEI Business Operations THEFACESHOP Co., Ltd. 688329416 label(51523-051) Establishment Name Address ID/FEI Business Operations ZENISCE Co., Ltd. 690188305 manufacture(51523-051)
