Label: NIVEA FOR MEN PROTECTIVE - octinoxate, avobenzone and oxybenzone lotion 

  • Label RSS
  • 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 06/12

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

  • ACTIVE INGREDIENT

    Active ingredients
    Avobenzone 2%
    Octinoxate 6%
    Oxybenzone 2%

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  • PURPOSE

    Purpose
    Sunscreen
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  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn
    • if used 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

    Warnings
    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin

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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 occurs

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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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  • QUESTIONS

    Questions or comments?
    1-800-227-4703 Close
  • DOSAGE & ADMINISTRATION

    Directions
    For sunscreen use:
    • apply liberally 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 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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  • INACTIVE INGREDIENT

    Inactive ingredients
    Water, Glycerin, Alcohol Denat.,
    Distarch Phosphate, Cyclomethicone,
    Butyrospermum Parkii (Shea)
    Butter, Cetearyl Alcohol, Glyceryl
    Stearate Citrate, Tocopheryl
    Acetate, Carbomer,Fragrance,
    Trisodium EDTA, Sodium Hydroxide,
    Titanium Dioxide, Alumina,
    Silica, Sodium Polyacrylate,
    Phenoxyethanol, Methylparaben,
    Methylisothiazolinone.

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  • PRINCIPAL DISPLAY PANEL

    NIVEA FOR MEN

    PROTECTIVE LOTION

    Broad Spectrum SPF 15
    Sunscreen

    Moisturizes and Protects

    nfmprotectivespf15dfbox

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  • INGREDIENTS AND APPEARANCE
    NIVEA FOR MEN PROTECTIVE 
    octinoxate, avobenzone, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10356-565
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (Octinoxate) Octinoxate 6 mL  in 100 mL
    Avobenzone (Avobenzone) Avobenzone 2 mL  in 100 mL
    Oxybenzone (Oxybenzone) Oxybenzone 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    ALCOHOL  
    CYCLOMETHICONE  
    SHEA BUTTER  
    CETOSTEARYL ALCOHOL  
    GLYCERYL STEARATE CITRATE  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    EDETATE TRISODIUM  
    SODIUM HYDROXIDE  
    ALUMINUM OXIDE  
    SILICON DIOXIDE  
    PHENOXYETHANOL  
    METHYLPARABEN  
    TITANIUM DIOXIDE  
    METHYLISOTHIAZOLINONE  
    SODIUM POLYACRYLATE (8000 MW)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10356-565-16 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 06/15/2012
    Labeler - Beiersdorf Inc (001177906)
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