NEUTROGENA ULTRA SHEER FACE SUNSCREEN SPF 60- avobenzone, homosalate, octisalate, octocrylene stick

Neutrogena Ultra Sheer Face Sunscreen SPF 60 by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Face Sunscreen SPF 60 by is a Otc medication manufactured, distributed, or labeled by KDC/One Development Corporation, Inc., KDC/One Development Corporation, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Avobenzone (3%),

Homosalate (15%),

Octisalate (5%),

Octocrylene (10%)

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.

Directions

apply liberally and evenly 15 minutes before sun exposure

▪ ensure complete coverage to the area above the lip, nose and tops of ears

▪ 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

package contains small parts, which could cause a choking hazard

Protect from freezing

Inactive ingredients

Neopentyl Glycol Diethylhexanoate, Octyldodecyl Neopentanoate, Synthetic Wax, Isohexadecane, Butyloctyl Salicylate, Ozokerite, Paraffin, Synthetic Beeswax, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ascorbyl Palmitate

Questions or comments?

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

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Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

Neutrogena Ultra Sheer Face Stick Sunscreen SPF 60 - 13 g Canister in Blister Pack Label

New

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

ULTRA SHEER ®

Face Stick

Sunscreen

60

BROAD

SPECTRUM

SPF 60

Antioxidants

Vitamin C & E

Invisible,

non-greasy

Shields skin

6 layers deep

with

HELIOPLEX ®

Fragrance Free

For sensitive skin

Water resistant

(80 minutes)

NET WT

0.47 OZ (13g)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER FACE SUNSCREEN SPF 60 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54565-1645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
CERESIN (UNII: Q1LS2UJO3A)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PARAFFIN (UNII: I9O0E3H2ZE)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54565-1645-2	1 in 1 BLISTER PACK	10/04/2024
1	NDC: 54565-1645-1	13 g in 1 CANISTER; 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	10/04/2024

Labeler - KDC/One Development Corporation, Inc. (204006464)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/One Development Corporation, Inc		204006464	analysis(54565-1645) , manufacture(54565-1645) , pack(54565-1645) , label(54565-1645)