NDC | 49967-431-01, 49967-431-02 |
Set ID | 071bfb80-d980-4e62-9cd6-96149f1ba04a |
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
- apply generously 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately fter towel drying
- at least every 2 hours
- 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 SOF calue of 15 or higher and other sun protection measures including:
- limit time in the sun, especially between 10 a.m. and 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, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, menthyl methacrylae crosspolymer, nylon-12, PEG-100, glyceryl stearate, perlite, beeswax, ammonium poolyacrylloyldiimethy taurate, behenyl alcohol, caprylic/capric triglyceride, cassia alata leaf extract, chlorphenesisn, diethylhexyl syringlyidenemalonate, disodium EDTA, maltodextrin, p-anisic acid, PEG-8 laurate, phenoxethanol, propylene glycol, sodium stearoyl glutamate, tocopherol, xanthan gum
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE SPORT ANTHELIOS ACTIVEWEAR BROAD SPECTRUM SPF 60 SUNSCREEN
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-431 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NYLON-12 (UNII: 446U8J075B) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PERLITE (UNII: 0SG101ZGK9) CHLORPHENESIN (UNII: I670DAL4SZ) MALTODEXTRIN (UNII: 7CVR7L4A2D) PEG-8 LAURATE (UNII: 762O8IWA10) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-431-01 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2017 2 NDC:49967-431-02 5 mL in 1 PACKET; Type 0: Not a Combination Product 10/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/17/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-431)