Your browser does not support JavaScript! NIVEA FOR MEN PROTECTIVE (OCTINOXATE, AVOBENZONE, OXYBENZONE) LOTION [BEIERSDORF INC]
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NIVEA FOR MEN PROTECTIVE (octinoxate, avobenzone, oxybenzone) lotion
[Beiersdorf Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredients
Avobenzone 2%
Octinoxate 6%
Oxybenzone 2%

Purpose
Sunscreen

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
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 a Poison Control
Center right away.

Questions or comments?
1-800-227-4703

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 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.

NIVEA FOR MEN

PROTECTIVE LOTION

Broad Spectrum SPF 15
Sunscreen

Moisturizes and Protects

nfmprotectivespf15dfbox

NIVEA FOR MEN PROTECTIVE 
octinoxate, avobenzone, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10356-565
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate6 mL  in 100 mL
Avobenzone (Avobenzone) Avobenzone2 mL  in 100 mL
Oxybenzone (Oxybenzone) Oxybenzone2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10356-565-1675 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/15/2012
Labeler - Beiersdorf Inc (001177906)

Revised: 6/2012
 
Beiersdorf Inc

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