Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS TINTED MINERAL LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 40 MEDIUM DEEP- titanium dioxide and zinc oxide lotion
- NDC Code(s): 49967-943-01, 49967-943-02
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 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.
-
Directions
- shake well before use
- apply generously 15 minutes before sun exposure
- apply to all skin exposed to the sun
- 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
-
Inactive ingredients
dimethicone, isohexadecane, triethylhexanoin, c15-19 alkane, dicaprylyl carbonate, silica, iron oxides, c12-15 alkyl benzoate, caprylyl methicone, butyloctyl salicylate, aluminum stearate, talc, dimethicone/PEG-10/15 crosspolymer, alumina, polyhydroxystearic acid, water, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, acrylates/dimethicone copolymer, aluminum hydroxide, stearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, triethoxycaprylylsilane, disteardimonium hectorite, disodium stearoyl glutamate, diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, dipropylene glycol, sodium citrate, caprylic/capric triglyceride
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS TINTED MINERAL LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 40 MEDIUM DEEP
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-943 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide 170 mg in 1 mL Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOHEXADECANE (UNII: 918X1OUF1E) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) C15-19 ALKANE (UNII: CI87N1IM01) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM STEARATE (UNII: U6XF9NP8HM) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) TALC (UNII: 7SEV7J4R1U) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) ALUMINUM OXIDE (UNII: LMI26O6933) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) PENTYLENE GLYCOL (UNII: 50C1307PZG) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) TOCOPHEROL (UNII: R0ZB2556P8) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SENNA ALATA LEAF (UNII: 4BXR6YZN92) MALTODEXTRIN (UNII: 7CVR7L4A2D) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM CITRATE (UNII: 1Q73Q2JULR) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-943-01 1 in 1 CARTON 12/15/2023 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-943-02 1 in 1 CARTON 12/15/2023 2 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 12/15/2023 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-943) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(49967-943)
