Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide lotion
- NDC Code(s): 49967-020-01, 49967-020-02, 49967-020-03, 49967-020-04
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- 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:
- 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 hoursSun 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, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethcone, iron oxides, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringlidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, disodium stearoyl glutamate, PEG-9
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) UNDECANE (UNII: JV0QT00NUE) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOHEXADECANE (UNII: 918X1OUF1E) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) NYLON-12 (UNII: 446U8J075B) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENETHYL BENZOATE (UNII: 0C143929GK) 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) FERRIC OXIDE RED (UNII: 1K09F3G675) 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) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PEG-8 LAURATE (UNII: 762O8IWA10) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SENNA ALATA LEAF (UNII: 4BXR6YZN92) MALTODEXTRIN (UNII: 7CVR7L4A2D) BENZOIC ACID (UNII: 8SKN0B0MIM) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-020-01 1 in 1 CARTON 01/30/2017 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:49967-020-02 1 in 1 CARTON 01/30/2017 2 3 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-020-03 1 in 1 CARTON 01/30/2017 3 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:49967-020-04 1 in 1 CARTON 01/30/2017 4 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 01/30/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-020) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(49967-020) Establishment Name Address ID/FEI Business Operations Goodier Cosmetics LLC 007317209 manufacture(49967-020)