OTC Medication Information: Nivea Men Protective

NIVEA MEN PROTECTIVE- avobenzone, octisalate and octocrylene lotion
Beiersdorf Inc

Active ingredients

Avobenzone 3%

Octisalate 4.7%

Octocrylene 8.4%

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, 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.

NIVEA MEN

PROTECTIVE LOTION

Broad Spectrum SPF 15 Sunscreen

Moisturizes and Protects

carton
(click image for full-size original)
NIVEA MEN PROTECTIVE avobenzone, octisalate, octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-566
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 4.7 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 8.4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
PANTHENOL
PHENOXYETHANOL
1,2-HEXANEDIOL
ETHYLHEXYLGLYCERIN
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
EDETATE TRISODIUM
SODIUM HYDROXIDE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
WATER
GLYCERIN
ALCOHOL
ISOPROPYL PALMITATE
STARCH, TAPIOCA
CETOSTEARYL ALCOHOL
GLYCERYL STEARATE CITRATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
ALOE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10356-566-16 75 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 11/01/2015 07/01/2024
Labeler — Beiersdorf Inc (001177906)

Revised: 12/2023 Beiersdorf Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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