Label: MELVITA PROSUN SPF 15 SUN  - titanium dioxide and zinc oxide cream 

  • 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

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

  • Active Ingredients

    Titanium Dioxide  5.905%                 
    Zinc Oxide           12%                   

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  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides moderate 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

    Keep out of the reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Apply liberally before sun exposure and as needed 

    Children under 6 months of age: ask a doctor  - Reapply as needed or after towel drying, swimming or sweating

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  • Other information

    Moderate 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

    Citrus Aurantium Dulcis FruitWater [Citrus Aurantium Dulcis (Orange)FruitWater]*, Caprylic/Capric Triglyceride, Aqua[Water], Helianthus Annuus Seed Oil [Helianthus Annuus (Sunflower) Seed Oil]*, Polyglyceryl-2 polyhydraystearate, Glycerin, Octyldecanol, Silica, Lauryl Laurate, Mangifera Indica Seed Oil [Mangifera Indica (Mango) Seed Butter], Sesamum Indicum Seed Oil [Sesamum Indicum (Sesame) Seed Oil]*, Simmondsia Chinensis Seed Oil [Simmondsia Chinensis (Jojoba) Seed Oil]*, Glyceryl Isostearate, Benzyl Alcohol, Olus Oil (Vegatable Oil), Polyglyceryl-3 Disostearate, Pongamol, Alumina, Stearic Acid, PolyhydroxyStearic Acid, Cera Alba [Beeswax], Magnesium Sulfate, Parfum [Fragrance], Tocopherol, Dehydroacetic Acid, Hydrogenated Vegetable Oil, Inositol, Sodium Phytate, Candelila Cera [Euphorbia Cerifera (Candelilla) Wax], Linalool**, Citronellol**, Limonene**, Alcohol.  * Ingredients from Organic Farming

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  • Description

    Packaging from sustainably managed forests and printed with vegetable inks.  SPF 15 sun cream medium protection - darker skin.  This nano-particle free formulation contains natural mineral sun filters to provide medium protection. The cream is recommended for darker skins, offering protection against A-type ultra-violet rays and helping towards a radiant, lasting tan. It is also recommended for moderate sun exposure. It owes its protective, moisturizing properties to the Pongamia extract, Mango butter and Sesame and Jojoba oils. Carob extract intensifies the quality of the tan and helps to sustain it. Usage instructions : apply generously to dry skin on the face and body before and during exposure to the sun. Renew the applications approximately every 2 hours and after swimming or sporting activities. Avoid the eye contour,  Sun advice : Choose your level of sun protection based on your skin type. Avoid exposure between 12.00 and 4.00 pm and do not extend your exposure time. Protect children from the sun' s direct rays and always shelter children under the age of 3.  Sun Protection indicee UVA and SPF calculated by an independent laboratory UVA protection complient with the European SPF/UVA Less than or equal to 3 ratio Critical wavelength Less than or equal to 370 mm 100% mineral origin sun block.  Natural and Organic Cosmetic certified by ECOCERT Greenlife according to ECOCERT Standard available at http://cosmetic.eccocert.com  98.95% of the total ingredients from natural origin. 32% of the total ingredients from Organic Farming.

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  • Purpose

    Sunscreen

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  • Melvita PROSUN SPF 15 Sun Cream 75ml (43611-002-00)
  • INGREDIENTS AND APPEARANCE
    MELVITA PROSUN SPF 15 SUN  
    titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43611-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 59.05 mg  in 1 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 120 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ORANGE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    WATER  
    SUNFLOWER OIL  
    GLYCERIN  
    OCTYLDECANOL  
    SILICON DIOXIDE  
    LAURYL LAURATE  
    MANGIFERA INDICA SEED BUTTER  
    SESAME OIL  
    SIMMONDSIA CHINENSIS SEED  
    GLYCERYL ISOSTEARATE  
    BENZYL ALCOHOL  
    PONGAMOL  
    ALUMINUM OXIDE  
    STEARIC ACID  
    POLYHYDROXYSTEARIC ACID (2300 MW)  
    MAGNESIUM SULFATE, UNSPECIFIED  
    TOCOPHEROL  
    DEHYDROACETIC ACID  
    INOSITOL  
    CANDELILLA WAX  
    LINALOOL, (+/-)-  
    .BETA.-CITRONELLOL, (R)-  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43611-002-00 1 in 1 BOX
    1 75 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/12/2011
    Labeler - Laboratoires M&L (263910193)
    Registrant - Laboratoires M&L (263910193)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratoires M&L 263910193 manufacture(43611-002)
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