NIVEA MEN MAXIMUM HYDRATION FACE- avobenzone, octisalate, octocrylene lotion

Nivea Men Maximum Hydration Face by

Drug Labeling and Warnings

Nivea Men Maximum Hydration Face 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, 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, Pantolactone, Citric Acid, Sodium Hydroxide,

Trisodium EDTA.

PRINCIPAL DISPLAY PANEL

NIVEA MEN

Maximum Hydration Face Lotion

Broad Spectrum SPF 15
Sunscreen

Moisturizes and Protects

Pro-vitamin B5 and Aloe Vera

INGREDIENTS AND APPEARANCE

NIVEA MEN MAXIMUM HYDRATION FACE 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-567
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
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALOE (UNII: V5VD430YW9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTOLACTONE (UNII: J288D7O0JS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-567-16	75 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2022

Labeler - Beiersdorf Inc (001177906)