Label: AMBI SUNSCREEN- avobenzone, octisalate , octocrylene and oxybenzone lotion

  • 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.

  • PURPOSE

    Sunscreen Lotion

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • QUESTIONS

    Call 1-800-321-4576

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  • DOSAGE & ADMINISTRATION

    Directions:      For sunscreen use, apply generously and every 15 minutes before sun exposure
                          Use a water resistant sunscreen if swimming or sweating
                          Reapply 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 AM - 2 PM
                          Wear long sleeved shirts, pants, hats and sunglasses
                          Children under 6 months of age ask a Doctor

                          Protect this product from excessive heat and direct sun.
                          May stain some fabric.

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  • ACTIVE INGREDIENT

    Avobenzone 3%
    Octisalate  5%
    Octocrylene 1.7%
    Oxybenzone 3%

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  • INACTIVE INGREDIENT

    Water,

    C12-15 Alkyl Benzoate

    Dimethicone

    Diethylhexyl 2

    6-Naphthalate

    Glycerin

    Arachidyl Alcohol

    Phenyl Trimethicone

    Sodium Polyacrylate

    Silica

    PCA Dimethicone

    Cetearyl Alcohol

    Phenoxyethanol

    Methyl Methacrylate

    Crosspolymer

    Behenyl Alcohol

    Aluminum Starch Octenylsuccinate

    Steareth - 2

    Betaine

    Fragrance

    Arachidyl Gluccoside

    Methylparaben

    Steareth - 21

    Disodium EDTA

    Hydroxypropyl Methylcellulose

    Cetearyl Gluccoside

    Sodium PCA

    Propylparaben

    Benzalkonium Chloride

    Sorbitol

    Ethylparaben

    Boron Nitride

    Serine

    Iodopropynyl Butylcarbonate

    Glycine

    Glutamic Acid

    Alanine

    Arginine

    Lysine

    Theonine

    Proline







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  • Label - KK1.jpg
  • INDICATIONS & USAGE

    Helps prevent sun burn if use as directed with other sun protection measures (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, 

    Do not use on damaged or broken skin.

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

    Stop use and ask a Doctor if rash occurs.

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


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  • INGREDIENTS AND APPEARANCE
    AMBI  SUNSCREEN
    avobenzone, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61047-825
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (Avobenzone) Avobenzone 1.77 g  in 59 g
    Octisalate (Octisalate) Octisalate 2.95 g  in 59 g
    Octocrylene (Octocrylene) Octocrylene 1.0 g  in 59 g
    Oxybenzone (Oxybenzone) Oxybenzone 1.77 g  in 59 g
    Inactive Ingredients
    Ingredient Name Strength
    Dimethicone  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61047-825-95 59 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/09/2013
    Labeler - KIK Custom Products (243547333)
    Registrant - KIK Operating Partnership (243547333)
    Establishment
    Name Address ID/FEI Business Operations
    KIK Custom Products 243547333 manufacture(61047-825)
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