NDC | 49967-789-01, 49967-789-02, 49967-789-03 |
Set ID | 8f18e74b-b903-429a-a3fb-9d233f7719b6 |
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
- Caution:
- 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
dimethicone, cyclohexasiloxane, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, disteardimonium hectorite, PEG-10 dimethicone, synthetic fluorphlogopite, water, propylene carbonate, disodium stearoyl glutamate, silica silylate, fragrance, calophyllum inophyllum seed oil, aluminum hydroxide, benzyl alcohol; may contain: titanium dioxide, iron oxides
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YVES SAINT LAURENT LE TEINT ENCRE DE PEAU FUSION INK FOUNDATION BROAD SPECTRUM SPF 18 SUNSCREEN
octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-789 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ISODODECANE (UNII: A8289P68Y2) ALCOHOL (UNII: 3K9958V90M) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) PROPYLENE CARBONATE (UNII: 8D08K3S51E) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) TAMANU OIL (UNII: JT3LVK84A1) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BENZYL ALCOHOL (UNII: LKG8494WBH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-789-01 1 in 1 CARTON 08/01/2014 1 25 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-789-02 1 in 1 CARTON 08/01/2014 2 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49967-789-03 0.27 mL in 1 PACKAGE; Type 0: Not a Combination Product 08/01/2014 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2014 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Sicos et Cie 276993581 manufacture(49967-789) Establishment Name Address ID/FEI Business Operations Laboratoires Biocosm SARL 288479491 pack(49967-789) Establishment Name Address ID/FEI Business Operations Socoplan 276221405 pack(49967-789)