NIVEA MEN SENSITIVE PROTECTIVE- avobenzone, octisalate, octocrylene lotion

Nivea Men Sensitive Protective by

Drug Labeling and Warnings

Nivea Men Sensitive Protective by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Avobenzone 3%
Octisalate 4.7%
Octocrylene 8.4%

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

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

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.

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, 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.

PRINCIPAL DISPLAY PANEL

NIVEA MEN

SENSITIVE

PROTECTIVE LOTION

Broad Spectrum SPF 15
Sunscreen

Moisturizes and Protects

.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4.7 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	8.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERIN (UNII: PDC6A3C0OX)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PANTHENOL (UNII: WV9CM0O67Z)
CHAMOMILE (UNII: FGL3685T2X)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
HEXANEDIOL (UNII: ZIA319275I)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE TRISODIUM (UNII: 420IP921MB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-575-16	75 mL in 1 TUBE; Type 0: Not a Combination Product	09/15/2014

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)