Label: CC TOTAL COVER CUSHION SPF 50 APRICOT BEIGE- ensulizole, titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-060-01 - 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
WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL, TROMETHAMINE, DIMETHICONE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, ZINC STEARATE, STEARIC ACID, SODIUM CHLORIDE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, GLYCERIN, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, HYALURONIC ACID, DIMETHICONOL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, DIMETHICONE CROSSPOLYMER, LAURYL DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, PALMITOYL PROLINE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SODIUM PALMITOYL SARCOSINATE, MAGNESIUM PALMITOYL GLUTAMATE, PALMITIC ACID, DIPROPYLENE GLYCOL, BORON NITRIDE, SODIUM CITRATE, TOCOPHEROL, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, PHENOXYETHANOL, PHYTOSPHINGOSINE, CHOLESTEROL, CERAMIDE AP, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CARBOMER, CERAMIDE EOP, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77491, CI 77492, CI 77499)
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL CC TOTAL COVER CUSHION BROAD SPECTRUM SPF 50 THEFACESHOP Net Wt. 0.52 oz | 15g
- THEFACESHOP CC TOTAL COVER CUSHION V201 APRICOT BEIGE [Broad Spectrum SPF 50] Net Wt. 0.52 oz | 15 g.
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INGREDIENTS AND APPEARANCE
CC TOTAL COVER CUSHION SPF 50 APRICOT BEIGE
ensulizole, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.819 g in 15 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 0.405 g in 15 g Inactive Ingredients Ingredient Name Strength DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) PHENOXYETHANOL (UNII: HIE492ZZ3T) CERAMIDE AP (UNII: F1X8L2B00J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BORON NITRIDE (UNII: 2U4T60A6YD) CERAMIDE NP (UNII: 4370DF050B) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER 940 (UNII: 4Q93RCW27E) CERAMIDE 1 (UNII: 5THT33P7X7) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PALMITOYL PROLINE (UNII: I49727TDYF) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ADENOSINE (UNII: K72T3FS567) MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48) PALMITIC ACID (UNII: 2V16EO95H1) CYCLOMETHICONE 6 (UNII: XHK3U310BA) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) MICA (UNII: V8A1AW0880) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF) DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) 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) HYALURONIC ACID (UNII: S270N0TRQY) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) NIACINAMIDE (UNII: 25X51I8RD4) TROMETHAMINE (UNII: 023C2WHX2V) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-060-01 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(51523-060) Establishment Name Address ID/FEI Business Operations ZENISCE Co., Ltd. 690188305 manufacture(51523-060)
