NIVEA MEN ENERGY REVITALIZING- avobenzone, octisalate, octocrylene lotion

Nivea Men Energy Revitalizing by

Drug Labeling and Warnings

Nivea Men Energy Revitalizing 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%

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.

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.

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

QUESTIONS

Questions or comments?
1-800-227-4703

INACTIVE INGREDIENT

Inactive ingredients

Water, Glycerin, C12-15 Alkyl Benzoate, Alcohol Denat., Isopropyl Palmitate, Tapioca

Starch, Cetearyl Alcohol, Glyceryl Stearate Citrate, Panthenol, Ca-eine, Creatine,

Ubiquinone, Sea Silt Extract, Oyster Shell Extract, 1,2-Hexanediol, Ethylhexylglycerin,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1-Methylhydantoin-2-Imide,

Zinc Citrate, Propylene Glycol, Fragrance, Carbomer, Sodium Hydroxide, Trisodium

EDTA, Phenoxyethanol, Benzoic Acid.

PRINCIPAL DISPLAY PANEL

NIVEA MEN

Energy

Revitalizing Lotion

Broad Spectrum SPF 15

Sunscreen

INGREDIENTS AND APPEARANCE

NIVEA MEN ENERGY REVITALIZING 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-572
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
STARCH, TAPIOCA (UNII: 24SC3U704I)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
PANTHENOL (UNII: WV9CM0O67Z)
UBIDECARENONE (UNII: EJ27X76M46)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE TRISODIUM (UNII: 420IP921MB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAFFEINE (UNII: 3G6A5W338E)
CREATINE (UNII: MU72812GK0)
OSTREA EDULIS SHELL (UNII: 49OY13BE7Z)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ZINC CITRATE (UNII: K72I3DEX9B)
1-METHYLHYDANTOIN (UNII: 0546H9UR1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-572-05	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2015

Labeler - Beiersdorf Inc (001177906)