Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV HYDRA DAILY INVISIBLE BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion
- NDC Code(s): 49967-312-01, 49967-312-02
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- 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.
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Directions
For sunscreen use:
● apply generously 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
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Inactive ingredients
water, glycerin, c15-19 alkane, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, panthenol, tocopherol, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, sodium hyaluronate, pentylene glycol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, citric acid, caprylic/capric triglyceride, polyglycerin-3
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV HYDRA DAILY INVISIBLE BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-312 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 70 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) GLYCERIN (UNII: PDC6A3C0OX) C15-19 ALKANE (UNII: CI87N1IM01) PROPANEDIOL (UNII: 5965N8W85T) PANTHENOL (UNII: WV9CM0O67Z) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BETASIZOFIRAN (UNII: 2X51AD1X3T) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SENNA ALATA LEAF (UNII: 4BXR6YZN92) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-312-01 1 in 1 CARTON 12/01/2023 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-312-02 1 in 1 CARTON 12/01/2023 2 5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2023 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA PRODUCTS, INC. 624244349 manufacture(49967-312) , pack(49967-312)
