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  5. Label Information: Nivea Men Protective

FDA Label for Nivea Men Protective

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - QUESTIONS
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nivea Men Protective Product Label

The following document was submitted to the FDA by the labeler of this product Beiersdorf Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients

Avobenzone 3%

Octisalate 4.7%

Octocrylene 8.4%


Otc - Purpose



Purpose
Sunscreen


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.


Warnings



Warnings
For external use only


Otc - Do Not Use



Do not use on damaged or broken skin


Otc - When Using



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


Otc - Stop Use



Stop use and ask a doctor if rash occurs


Otc - 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.


Otc - Questions



Questions or comments?
1-800-227-4703


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


Inactive Ingredient



Inactive ingredients:

Water, Isopropyl Palmitate, Glycerin, Alcohol Denat.,

Tapioca Starch, Cetearyl Alcohol, Glyceryl

Stearate Citrate, Aloe Barbadensis Leaf Juice

Powder, Panthenol, Tocopheryl Acetate,

Phenoxyethanol, 1,2-Hexanediol,

Carbomer, Fragrance, Ethylhexylglycerin,

Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Sodium Hydroxide,

Trisodium EDTA.


* Please review the disclaimer below.