NDC | 49967-403-01, 49967-403-02 |
Set ID | 2dc9c98e-eecb-4537-9fc0-af95cdff616f |
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
- Flammable until dry.
- 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 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
water, dimethicone, isododecane, alcohol, trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, titanium dioxide, perlite, nylon-12, lauryl methacrylate/glycol dimethacrlyate crosspolymer, HDI/trimethylol hexyllactone crosspolymer, bismuth oxychloride, BIS-PEG/PPG-14/14 dimethicone, magnesium sulfate, silica silylate, phenoxyethanol, disteardimonium hectorite, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, hydrogen dimethicone, tocopherol, propylene glycol, silica, iron oxides, BHT, synthetic fluorphlogopite, rosa centifolia flower extract, disodium stearoyl glutamate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
YVES SAINT LAURENT ALL HOURS PRIMER BROAD SPECTRUM SPF 18 SUNSCREEN
octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 65 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ISODODECANE (UNII: A8289P68Y2) ALCOHOL (UNII: 3K9958V90M) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PERLITE (UNII: 0SG101ZGK9) NYLON-12 (UNII: 446U8J075B) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-403-01 1 in 1 CARTON 06/01/2017 1 40 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-403-02 1 mL in 1 PACKET; Type 0: Not a Combination Product 06/01/2017 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-403) Establishment Name Address ID/FEI Business Operations BPS60 272259304 pack(49967-403)