Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion
- NDC Code(s): 49967-126-01, 49967-126-02
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- 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, isononyl isononanoate, glycerin, dimethicone, aluminum starch octenylsuccinate, sucrose tristearate, polymethylsilsesquioxane, polysorbate 61, PEG-12 dimethicone, carbomer, triethanolamine, dimethiconol, sodium hyaluronate, sodium stearoyl glutamate, disodium EDTA, hydrolyzed hylauronic acid, caprylyl glycol, xanthan gum, sodium benzoate, phenoxyethanol, fragrance
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-126 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 47 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) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SUCROSE TRISTEARATE (UNII: 71I93STU5M) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) POLYSORBATE 61 (UNII: X9E1MY2JQG) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-126-01 1 in 1 CARTON 09/01/2012 09/01/2012 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-126-02 1 in 1 CARTON 09/01/2012 2 50 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 09/01/2012 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-126) , pack(49967-126)
