Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL DAILY TONE CORRECTING PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide lotion

  • NDC Code(s): 49967-525-01, 49967-525-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 27, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Titanium dioxide 25%

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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
    • if used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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  • Warnings

    For external use only

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  • Do not use

    on damaged or broken skin

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  • When using tjhis product

    keep out of eyes. Rinse with water to remove.

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  • Stop use and ask a doctor if

    rash occurs

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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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 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 of 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

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  • Other information

    • protect the product in this container from excessive heat and direct sun
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  • Inactive ingredients

    dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 lasurate, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyl glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

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  • Questions or comments?

    1-888-LRP-LABO  1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. EST)

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  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL DAILY TONE CORRECTING PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN 
    titanium dioxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-525
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    LAURETH-4 (UNII: 6HQ855798J)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49967-525-01 1 in 1 CARTON 01/01/2016
    1 40 mL in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:49967-525-02 2 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2016
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    Name Address ID/FEI Business Operations
    Goodier Cosmetics LP 007317209 manufacture(49967-525)
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