| NDC | 49967-048-01, 49967-048-02 |
| Set ID | e1310453-1880-43a5-982b-cf9b30cfdc47 |
| 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.
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Directions
For sunscreen use:
● apply generously 15 minutes before sun exposure
● reapply:
● after 80 minutes of swimming or sweating
● immediately after 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 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
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Inactive ingredients
water, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, methyl methacrylate crosspolymer, nylon-12, PEG-100 stearate, glyceryl stearate, perlite, beeswax, ammonium polyacryloyldimethyl taurate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, sodium stearoyl glutamate, chlorphenesin, p-anisic acid, xanthan gum, tocopherol, disodium EDTA, arachidyl alcohol, diethylhexyl syringylidenemalonate, propylene glycol, cassia alata leaf extract, maltodextrin, stearyl alcohol, t-butyl alcohol, caprylic/capric triglyceride
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS CLEAR SKIN FACE OIL FREE DRY TOUCH BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-048 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NYLON-12 (UNII: 446U8J075B) PEG-100 STEARATE (UNII: YD01N1999R) PERLITE (UNII: 0SG101ZGK9) YELLOW WAX (UNII: 2ZA36H0S2V) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-8 LAURATE (UNII: 762O8IWA10) DOCOSANOL (UNII: 9G1OE216XY) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CHLORPHENESIN (UNII: I670DAL4SZ) P-ANISIC ACID (UNII: 4SB6Y7DMM3) XANTHAN GUM (UNII: TTV12P4NEE) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SENNA ALATA LEAF (UNII: 4BXR6YZN92) MALTODEXTRIN (UNII: 7CVR7L4A2D) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-048-01 1 in 1 CARTON 01/01/2016 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-048-02 3 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2015 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-048)
