Label: ANGELICA UV SHIELD SPF 40 - titanium dioxide cream 

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  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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  • ACTIVE INGREDIENT:

    TITANIUM DIOXIDE 11.52%                 

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  • Uses:

    - Helps prevent sunburn. 

    - Higher SPF gives more sunburn protection. 

    - Provides high protection against sunburn.

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  • Warnings

    - For external use only.

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  • When using this product:

    - Keep out of eyes. Rinse with water to remove.

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  • Stop use and ask doctor if:

    - Rash or irritation develops and lasts.

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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:

    - Apply evenly each morning before sun exposure. Reapply as needed.  - Do not use on infants under 6 months.

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  • Other Safety Information Section

    High sun protection product  sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

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  • INACTIVE INGREDIENTS:

    CYCLOMETHICONE - AQUA/WATER** - GLYCERIN** - POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE - CORN STRARCH MODIFIED** - ALUMINUM HYDROXIDE** - STEARIC ACID** - METHYLSILANOL MANNURONATE - PEG-12 DIMETHICONE - SODIUM CHLORIDE** - ANGELICA ARCHANGELICA ROOT EXTRACT* - ANGELICA ARCHANGELICA ROOT OIL* - BORAGO OFFICINALIS SEED OIL** - AMYRIS BALSAMIFERA BARK OIL** - MENTHA PIPERITA (PEPPERMINT) OIL** - SORBITOL** - ANHYDROXYLITOL** - PEG/PPG-18/18 DIMETHICONE - XYLITYLGLUCOSIDE** - XYLITOL** - ETHYLHEXYLGLYCERIN - TOCOPHERYL ACETATE - HYDROLYZED VIOLA TRICOLOR EXTRACT** - PHENOXYETHANOL - PARFUM (FRAGRANCE) - CHLORPHENSIN - SODIUM BENZOATE - POTASSIUM BENZOATE - SORBIC ACID - TOCOPHEROL** - LIMONENE. *Ingredients from Organic Farming. Natural origin ingredients.

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  • Description

    BREVENT DEPOSE L'OCCITANE EN PROVENCE PATENT PENDING  Angelica is an astonishing plane. It can grow to a height of up to two meters in just a few days, thanks to its exceptional capacity for self-hydration.  L'OCCITANE has discovered and patented the effectiveness of this unique plant for its skin hydration benefits, and ability to bring vitality. At the heart of the UV shield SPF 40 is selected an organic angelica from the Drome region.  Action: skin is immediately and lastingly MOISTURIZED and REVITALIZED.  Result: skin is PLUMP, SMOOTHED and RADIANT.  Tolerance dermatologically tested.  Non-comedogenic formula.  Patent pending in France.  The patented angelica complex in the light and silky smooth UV Sheild SPF 40 contains:  - Angelica water - Enhances the skin's natural hydration by stimulating aquaporins - true "water channels" which ensure that moisture is both diffused and brought in the heart of cells; - Angelica essential oil-help to improve skin elasticity and to preserve from free radicals; - UVA and UVB filters help to protect the skin against the damaging effect to sun. Apply to the face and neck every morning, alone or on top of your regular moisturizer.  L'OCCITANE - 04100 Manosque www.loccitane.com - Made in France  6 M 36BV030A 1  3  253581 197363

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  • Purpose

    Sunscreen

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  • Product Inner Label
  • Product Outer Label 1
  • Product Outer Label 2
  • INGREDIENTS AND APPEARANCE
    ANGELICA UV SHIELD SPF 40 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10345-018
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 115.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CYCLOMETHICONE  
    WATER  
    GLYCERIN  
    STARCH, CORN  
    ALUMINUM HYDROXIDE  
    STEARIC ACID  
    DIMETHICONE  
    SODIUM CHLORIDE  
    ANGELICA ARCHANGELICA ROOT  
    ANGELICA ROOT OIL  
    BORAGE OIL  
    AMYRIS BALSAMIFERA OIL  
    PEPPERMINT OIL  
    SORBITOL  
    ANHYDROXYLITOL  
    XYLITYLGLUCOSIDE  
    XYLITOL  
    ETHYLHEXYLGLYCERIN  
    PHENOXYETHANOL  
    SODIUM BENZOATE  
    POTASSIUM BENZOATE  
    SORBIC ACID  
    TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10345-018-01 1 in 1 PACKAGE
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/10/2011
    Labeler - LABORATOIRES M&L (262533623)
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