Label: NIVEA FOR MEN PROTECTIVE - octinoxate, avobenzone and oxybenzone lotion
- NDC Code(s): 10356-565-16
- Packager: Beiersdorf Inc
- 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.
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
• 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.
For external use only
- DO NOT USE
Do not use on damaged or broken skinClose
- WHEN USING
When using this product keep out of eyes.Close
Rinse with water to remove.
- STOP USE
Stop use and ask a doctor if rash occursClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed,Close
get medical help or contact a Poison Control
Center right away.
Questions or comments?
- DOSAGE & ADMINISTRATION
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
Water, Glycerin, Alcohol Denat.,
Distarch Phosphate, Cyclomethicone,
Butyrospermum Parkii (Shea)
Butter, Cetearyl Alcohol, Glyceryl
Stearate Citrate, Tocopheryl
Trisodium EDTA, Sodium Hydroxide,
Titanium Dioxide, Alumina,
Silica, Sodium Polyacrylate,
- PRINCIPAL DISPLAY PANEL
NIVEA FOR MEN
Broad Spectrum SPF 15
Moisturizes and Protects
- 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)