Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
- NDC Code(s): 49967-392-01, 49967-392-02
- 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 July 22, 2014
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- Active ingredients
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sunClose
For external use onlyClose
- Do not use
on damaged or broken skinClose
- When using this product
keep out of eyes. Rinse with water to remove.Close
- Stop use and ask a doctor if
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
For sunscreen use:
● apply generously 15 minutes before sun exposure
● 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 doctorClose
- Other information
protect the product in this container from excessive heat and direct sunClose
- Inactive ingredients
water, alcohol denat., dimethicone, cyclopentasiloxane, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, capryly glycol, sodium polyacrylate, silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, tocopherol, methyl lactate, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrinClose
- Questions or comments?
Monday - Friday (9 a.m. - 5 p.m. EST)Close
- INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-392 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 22.4 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 24 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 44.8 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 28.8 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-392-01 150 mL in 1 TUBE 2 NDC:49967-392-02 5 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2014 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, INC. 185931458 manufacture(49967-392)