NDC | 49967-787-01, 49967-787-02, 49967-787-03, 49967-787-04 |
Set ID | 6c8f7aa2-ce4a-4720-ae5e-dd33c48f2e5e |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredient
- 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, cyclopentasiloxane, glycerin, dimethicone, isododecane, PEG-10 dimethicone, sorbitol, bis-PEG/PPG-14/14 dimethicone, synthetic fluorphlogopite, sodium chloride, silica, dimethicone/polyglycerin-3 crosspolymer, phenoxyethanol, methyl methacrylate crosspolymer, capryly glycol, disodium stearoyl glutamate, disteardimonium hectorite, silica silylate, tocopheryl acetate, ethylhexylglycerin, fragrance, aluminum hydroxide, ascorbyl palmitate, ethylhexyl hydroxystearate, triethoxycaprylylsilane, dipropylene glycol, ruscus aculeatus root extract, BHT, tocopherol, sodium citrate, isopropyl alcohol ; may contain : titanium dioxide, iron oxides, bismuth oxychloride
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YVES SAINT LAURENT TOUCHE ECLAT LE TEINT RADIANCE AWAKENING FOUNDATION BROAD SPECTRUM SPF 22 SUNSCREEN
octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-787 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 68 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SORBITOL (UNII: 506T60A25R) BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ASCORBYL PALMITATE (UNII: QN83US2B0N) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIPROPYLENE GLYCOL (UNII: E107L85C40) RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM CITRATE (UNII: 1Q73Q2JULR) ISOPROPYL ALCOHOL (UNII: ND2M416302) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-787-01 1 in 1 CARTON 07/01/2015 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:49967-787-02 1 in 1 CARTON 07/01/2015 2 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49967-787-03 1 mL in 1 PACKET; Type 0: Not a Combination Product 07/01/2015 4 NDC:49967-787-04 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2015 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Sicos et Cie 276993581 manufacture(49967-787) , pack(49967-787) Establishment Name Address ID/FEI Business Operations Laboratoires Biocosm SARL 288479491 pack(49967-787) Establishment Name Address ID/FEI Business Operations Socoplan 276221405 pack(49967-787)