NEUTROGENA ULTRA SHEER MOISTURIZING FACE SERUM SUNSCREEN BROAD SPECTRUM SPF 60 PLUS- avobenzone, homosalate, octisalate, and octocrylene lotion

Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 13.5%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 10%	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

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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

Other information

• protect this product from excessive heat and direct sun
• May stain some fabrics

Inactive ingredients

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Dimethicone, Aluminum Starch Octenylsuccinate, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Sodium Hydroxide

Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 50 mL Carton Label

NEW

Neutrogena ®

DERMATOLOGIST

RECOMMENDED BRAND

Ultra Sheer ®

moisturizing

face serum

sunscreen

BROAD SPECTRUM

SPF 60+

FRAGRANCE FREE

60+

WITH VITAMIN E

soft + weightless

all-day hydration

oxybenzone free

water resistant (80 minutes)

1.7 FL OZ (50 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER MOISTURIZING FACE SERUM SUNSCREEN BROAD SPECTRUM SPF 60 PLUS 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0717
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	135 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYURETHANE-62 (UNII: TBK645J3J8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0717-2	1 in 1 CARTON	12/07/2021
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/07/2021

Labeler - Kenvue Brands LLC (118772437)