OTC Medication Information: Nivea Men Sensitive Protective

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

Disclaimer: 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.

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, Tapioca Starch, Cetearyl
Alcohol, Glyceryl Stearate Citrate, Tocopheryl Acetate, Panthenol,
Chamomilla Recutita (Matricaria) Flower Extract, Hamamelis
Virginiana (Witch HazeL) Bark/Leaf Extract, 1,2-Hexanediol, Carbomer,
Ethylhexylglycerin, Maltodextrin, Caprylic/Capric Triglyceride,
Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide,
Trisodium EDTA, Phenoxyethanol, Piroctone OIamine, Fragrance.

NIVEA MEN

Sensitive Face Lotion

Broad Spectrum SPF 15 Sunscreen

Moisturizes and Protects

No Drying Alcohol

NIVEA MEN SENSITIVE PROTECTIVE avobenzone, octisalate, octocrylene lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-575 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 WATER ISOPROPYL PALMITATE GLYCERIN STARCH, TAPIOCA CETOSTEARYL ALCOHOL GLYCERYL STEARATE CITRATE .ALPHA.-TOCOPHEROL ACETATE, DL- PANTHENOL CHAMOMILE HAMAMELIS VIRGINIANA TOP HEXANEDIOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ETHYLHEXYLGLYCERIN MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM HYDROXIDE EDETATE TRISODIUM PHENOXYETHANOL PIROCTONE OLAMINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10356-575-16 75 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/15/2014

Labeler — Beiersdorf Inc (001177906)

Revised: 12/2022 Beiersdorf Inc