Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
- NDC Code(s): 49967-008-01
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 18, 2018
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- Active ingredients
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
For sunscreen use:
● spray generously and spread evenly by hand 15 minutes before sun exposure
● hold container 4 to 6 inches from the skin to apply
● do not spray directly into face. Spray on hands then apply to face.
● do not apply in windy conditions
● use in a well-ventilated area
● 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
water, dimethicone, isopropyl lauroyl sarcosinate, glycerin, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, propylene glycol, caprylyl glycol, sodium stearoyl glutamate, polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, disodium EDTA, tocopherol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 26.8 mg in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 96 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 28.8 mg in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 53.8 mg in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 34.6 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-008-01 143 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2014 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 manufacture(49967-008) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 960317444 manufacture(49967-008) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-008)