NDC | 49967-674-01, 49967-674-02 |
Set ID | d53effa1-b5b2-49a5-90b8-8fe676c3a20d |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
● shake well before use
● apply generously 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
water, dimethicone, glycerin, alcohol denat., isododecane, PEG-10 dimethicone, dipropylene glycol, pentylene glycol, disteardimonium hectorite, betaine, talc, diisostearyl malate, fragrance, tocopheryl acetate, macadamia ternifolia seed oil, hydroxypropyl tetrahydropyrantriol, hydrolyzed prunus domestica, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, tin oxide, linalool, propylene glycol, copper gluconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, carrageenan, passiflora edulis seed oil, disodium stearoyl glutamate, disodium phosphate, butylene glycol, BHT, citric acid, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: mica, red 28 lake, red 7, iron oxides, carmine, ferric ammonium ferrocyanide, bismuth oxychloride, titanium dioxide
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YVES SAINT LAURENT TOP SECRETS CC PRIMER COLOR CORRECTING PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-674 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) ISODODECANE (UNII: A8289P68Y2) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) BETAINE (UNII: 3SCV180C9W) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MACADAMIA OIL (UNII: 515610SU8C) HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1) PHENOXYETHANOL (UNII: HIE492ZZ3T) ADENOSINE (UNII: K72T3FS567) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) JOJOBA OIL (UNII: 724GKU717M) LIMONENE, (+)- (UNII: GFD7C86Q1W) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) STANNIC OXIDE (UNII: KM7N50LOS6) LINALOOL, (+/-)- (UNII: D81QY6I88E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COPPER GLUCONATE (UNII: RV823G6G67) CORIANDER OIL (UNII: 7626GC95E5) MORINGA OLEIFERA SEED (UNII: TIX5482832) CARRAGEENAN (UNII: 5C69YCD2YJ) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHICONE (20 CST) (UNII: 6777U11MKT) APRICOT KERNEL OIL (UNII: 54JB35T06A) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MICA (UNII: V8A1AW0880) D&C RED NO. 7 (UNII: ECW0LZ41X8) FERRIC OXIDE RED (UNII: 1K09F3G675) CARMINIC ACID (UNII: CID8Z8N95N) FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-674-01 1 in 1 CARTON 03/01/2017 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-674-02 1 mL in 1 PACKET; Type 0: Not a Combination Product 03/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2017 Labeler - L'Oreal USA Products Inc. (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-674) , pack(49967-674) Establishment Name Address ID/FEI Business Operations Laboratoires Biocosm SARL 288479491 pack(49967-674) Establishment Name Address ID/FEI Business Operations Socoplan 276221405 pack(49967-674)