Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion
- NDC Code(s): 69625-908-01, 69625-908-02, 69625-908-03
- Packager: Cosmetique Active Production
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 13, 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
- shake well before use
- apply generously 15 minutes before sun exposure
- reapply:
- after 40 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
-
Inactive ingredients
water, dimethicone, isododecane, C12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene/acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, PEG-9
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69625-908 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide 60 mg in 1 mL Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) UNDECANE (UNII: JV0QT00NUE) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOHEXADECANE (UNII: 918X1OUF1E) NYLON-12 (UNII: 446U8J075B) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENETHYL BENZOATE (UNII: 0C143929GK) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIDECANE (UNII: A3LZF0L939) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DICAPRYLYL ETHER (UNII: 77JZM5516Z) TALC (UNII: 7SEV7J4R1U) ALUMINUM STEARATE (UNII: U6XF9NP8HM) PENTYLENE GLYCOL (UNII: 50C1307PZG) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM OXIDE (UNII: LMI26O6933) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEG-8 LAURATE (UNII: 762O8IWA10) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE CARBONATE (UNII: 8D08K3S51E) MALTODEXTRIN (UNII: 7CVR7L4A2D) BENZOIC ACID (UNII: 8SKN0B0MIM) POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69625-908-01 1 in 1 CARTON 07/01/2011 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69625-908-02 1 in 1 CARTON 07/01/2011 07/01/2011 2 3 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69625-908-03 1 in 1 CARTON 12/02/2019 3 5 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 07/01/2011 Labeler - Cosmetique Active Production (282658798) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(69625-908) , pack(69625-908) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(69625-908)