Label: PRADA REVEAL SKIN OPTIMIZING FOUNDATION BROAD SPECTRUM SPF 17 SUNSCREEN- ensulizole liquid
- NDC Code(s): 49967-380-01, 49967-380-02, 49967-380-03
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Flammable until dry.
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen use:
● shake well before use
● apply liberally 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if 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. – 2 p.m.
● wear long-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor
- Other information
-
Inactive ingredients
dimethicone, water, isododecane, alcohol denat., trimethylsiloxysilicate, propylene glycol, PEG/PPG-18/18 dimethicone, glycerin, niacinamide, silica, synthetic fluorphlogopite, polysilicone-11, hydroxyethylpiperazine ethane sulfonic acid, sodium chloride, phenoxyethanol, PEG-10 dimethicone, silica silylate, sodium hydroxide, disodium stearoyl glutamate, tocopherol, fragrance, alpha-glucan oligosaccharide, aluminum hydroxide, polymnia sonchifolia root juice, limonene, maltodextrin, alpha-isomethyl ionone, lactobacillus, geraniol, citronellol, citric acid; may contain: titanium dioxide, iron oxides
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRADA REVEAL SKIN OPTIMIZING FOUNDATION BROAD SPECTRUM SPF 17 SUNSCREEN
ensulizole liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 27 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) ALCOHOL (UNII: 3K9958V90M) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SODIUM HYDROXIDE (UNII: 55X04QC32I) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) LIMONENE, (+)- (UNII: GFD7C86Q1W) MALTODEXTRIN (UNII: 7CVR7L4A2D) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LACTOBACILLUS ACIDOPHILUS BCMC 12130 (UNII: MVC2243UZX) GERANIOL (UNII: L837108USY) CITRONELLOL ACETATE, (S)- (UNII: 78RZL4H51H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-380-01 1 in 1 CARTON 06/01/2023 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-380-02 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2023 3 NDC:49967-380-03 1 mL in 1 PACKET; Type 0: Not a Combination Product 06/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/01/2023 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-380) Establishment Name Address ID/FEI Business Operations BPS 60 272259304 pack(49967-380) Establishment Name Address ID/FEI Business Operations Socoplan 276221405 pack(49967-380)
