Label: PRISME PRIMER COLOR CORRECTING PRIMER SPF 20 PA SHADE 03 JAUNE- octinoxate, titanium dioxide cream
- NDC Code(s): 60905-0063-1
- Packager: LVMH Fragrance Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Use
- For external use only
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
aqua (water), cyclopentasiloxane, butylene glycol, alcohol, cetyl peg/ppg-10/1 dimethicone, phenyl trimethicone, phenoxyethanol, sorbitan sesquioleate, aluminum hydroxide, dimethicone, stearic acid, disteardimonium hectorite, sodium myristoyl glutamate, calcium gluconate, tetrasodium EDTA, parfum (fragrance), propylene carbonate, viola tricolor extract, pentylene glycol, hydrolyzed rice protein, magnesium aspartate, zinc gluconate, BHT, ethylhexylglycerin, geraniol, rosa multiflora fruit extract, magnolia obovata bark extract, copper gluconate, pentaerythrityltetra-di-t-butyl hydroxyhydrocinnamate, tocopherol. [May contain: mica, CI 77891 (titanium dioxide), CI 77492 - CI 77491 (iron oxides)].
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INGREDIENTS AND APPEARANCE
PRISME PRIMER COLOR CORRECTING PRIMER SPF 20 PA SHADE 03 JAUNE
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60905-0063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE (UNII: 92RU3N3Y1O) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W) CALCIUM GLUCONATE (UNII: SQE6VB453K) EDETATE SODIUM (UNII: MP1J8420LU) PROPYLENE CARBONATE (UNII: 8D08K3S51E) VIOLA TRICOLOR (UNII: 9Q24RAI43V) PENTYLENE GLYCOL (UNII: 50C1307PZG) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GERANIOL (UNII: L837108USY) ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27) MAGNOLIA OBOVATA BARK (UNII: SM9Z2LD5TK) COPPER GLUCONATE (UNII: RV823G6G67) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) TOCOPHEROL (UNII: R0ZB2556P8) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60905-0063-1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2018 Labeler - LVMH Fragrance Brands (275474252) Establishment Name Address ID/FEI Business Operations LVMH Fragrance Brands 394954143 manufacture(60905-0063)
