Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE MELA B3 UV DAILY SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and octocrylene lotion
- NDC Code(s): 49967-113-01, 49967-113-02
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 18, 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 resistat 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 meausures 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, c15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, butyrospermum parkii (shea) butter, tin oxide, potassium hydroxide, carbomer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, 2-mercaptonicotinoyl glycine, sodium dilauramidoglutamide lysine, sodium thiosulfate, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, red 4, mica, fragrance
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE MELA B3 UV DAILY SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-113 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 100 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) C15-19 ALKANE (UNII: CI87N1IM01) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SHEA BUTTER (UNII: K49155WL9Y) STANNIC OXIDE (UNII: KM7N50LOS6) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) SODIUM THIOSULFATE (UNII: HX1032V43M) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) XANTHAN GUM (UNII: TTV12P4NEE) PENTYLENE GLYCOL (UNII: 50C1307PZG) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C RED NO. 4 (UNII: X3W0AM1JLX) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-113-01 1 in 1 CARTON 10/15/2023 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-113-02 1 in 1 CARTON 10/15/2023 2 3 mL in 1 TUBE; 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 10/15/2023 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-113) , pack(49967-113)
