NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- avobenzone, homosalate, octisalate, and octocrylene stick

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 Plus by

Drug Labeling and Warnings

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 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 15%	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 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
• After use, twist stick down prior to capping to ensure complete closure.

Other information

• protect this product from excessive heat and direct sun
• may stain some fabrics
• 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, Fragrance, BHT

Questions?

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

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Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 42 g Canister Label

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Beach

Defense ®

water + sun protection

sunscreen stick

BROAD SPECTRUM SPF 50+

50+

helioplex ®

broad spectrum uvauvb

water resistant (80minutes)

NET WT. 1.5 OZ. (42 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50 PLUS 
avobenzone, homosalate, octisalate, and octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0899
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0899-2	42 g in 1 CANISTER; Type 0: Not a Combination Product	10/07/2019
2	NDC: 69968-0899-3	2 in 1 CARTON	10/07/2019
2		42 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	10/07/2019

Labeler - Johnson & Johnson Consumer Inc. (118772437)