Label: SAVONE SKIN THERAPY AGE ESSENTIALS SPF 30 SPORTS SUNSCREEN - octinoxate, octisalate and oxybenzone spray 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 03/11

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  • ACTIVE INGREDIENT

    Active ingredients                                                       Purpose Octyl methyoxycinnamate 7.5% .................................Sunscreen
    Octyl salicylate 3.0% .................................................Sunscreen
    Oxybenzone 5.0% ......................................................Sunscreen

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  • PURPOSE

    Uses:  Helps prevent sunburn, provides high protection against sunburn and tanning, For skin highly sensitive to sunburn

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  • WARNINGS

    Warnings:
    For external use only.

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  • WHEN USING

    When using this product; keep out of eyes, Rinse with water to remove.

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  • STOP USE

    Stop use and ask a doctor if; rash or irritation develops and lasts.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    Directions:  - apply evenly before sun exposure; - children under 6 months of age; ask a doctor; -reapply as needed or after towel drying, swimming, or sweating.

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  • SPL UNCLASSIFIED SECTION

    Other information:  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 sun.

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  • INACTIVE INGREDIENT

    Inactive ingredients:  Agaricus bisporus (mushroom) betaglucans, ascorbyl palmitate (vitamin C), chamomilla recutita (chamomile) flower extract, cucumis sativus (cucumber) fruit extract, DMDM hydanoin, ethyl ester of PVM/MA copolymer, polysorbate-20, parfum (fragrance), retinyl palmitate (vitamin A), rosa capina fruit (rose hips) oil, SD alcohol 40B, sodium PCA, tocopheryl acetate (vitamin E).

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  • DESCRIPTION

    NO ANIMAL TESTING  Carefully Manufactured for Herbal Authority 4320 Veterans Memorial Hwy., Holbrook, NY 11741   18752 00A  Herbal Authority 2008 B18752

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  • PRINCIPAL DISPLAY PANEL

    SAVONE SKIN THERAPY  AGE ESSENTIALS  SPF 30 SPORTS SPRAY Sunscreen High UV Protection Dries Instantly  -Helps Prevent Sunburn -Higher SPF Gives More Sunburn Protection -Provides High Protection Against Sunburn and Tanning -For Skin Highly Sensitive to Sunburn    8 FL. OZ. (236 mL)

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  • INGREDIENTS AND APPEARANCE
    SAVONE SKIN THERAPY AGE ESSENTIALS SPF 30 SPORTS SUNSCREEN 
    octinoxate, octisalate, oxybenzone spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76067-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 3.0 mL  in 100 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 5.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CULTIVATED MUSHROOM  
    ASCORBYL PALMITATE  
    CHAMOMILE  
    CUCUMBER  
    DMDM HYDANTOIN  
    POLYSORBATE 20  
    ROSA CANINA FRUIT OIL  
    SODIUM PYRROLIDONE CARBOXYLATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76067-100-08 236 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/11/2011
    Labeler - Herbal Authority (966845534)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source Inc. 969241041 manufacture
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