Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS HA MINERAL BROAD SPECTRUM SPF 30 DAILY MOISTURIZING SUNSCREEN- titanium dioxide and zinc oxide cream
- NDC Code(s): 49967-460-01, 49967-460-02, 49967-460-03
- 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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- 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 resistant sunscreen after 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
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Inactive ingredients
water, glycerin, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, c12-15 alkyl benzoate, polyglyceryl-4 isostearate, dimethicone, caprylyl methicone, ethylene/acrylic acid copolymer, caprylic/capric triglyceride, triethylhexanoin, silica, poly c10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, panthenol, diethylhexyl syringylidenemalonate, aluminum hydroxide, stearic acid, aluminum stearate, sodium hyaluronate, triethoxycaprylylsilane, chlorphenesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, trisodium ethylenediamine disuccinate, tocopherol, p-anisic acid, capryloyl salicylic acid, xanthan gum, propylene carbonate, cassia alata leaf extract, maltodextrin
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS HA MINERAL BROAD SPECTRUM SPF 30 DAILY MOISTURIZING SUNSCREEN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-460 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 55 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DICAPRYLYL ETHER (UNII: 77JZM5516Z) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PANTHENOL (UNII: WV9CM0O67Z) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM STEARATE (UNII: U6XF9NP8HM) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) TOCOPHEROL (UNII: R0ZB2556P8) P-ANISIC ACID (UNII: 4SB6Y7DMM3) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SENNA ALATA LEAF (UNII: 4BXR6YZN92) MALTODEXTRIN (UNII: 7CVR7L4A2D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-460-01 1 in 1 CARTON 12/01/2020 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-460-02 1 in 1 CARTON 12/01/2020 2 5 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-460-03 2 mL in 1 PACKET; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2020 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, INC. 185931458 manufacture(49967-460)
