NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, and octocrylene lotion

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 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 2.5%	Sunscreen
Homosalate 6%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 8%	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 generously 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, Silica, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Benzyl Alcohol, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Caprylyl Glycol, Synthetic Beeswax, Cetyl Dimethicone, Ethylhexylglycerin, Hydrolyzed Jojoba Esters, Behenyl Alcohol, Fragrance, Xanthan Gum, Sodium Polyacrylate, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disodium EDTA, Ethylhexyl Stearate, BHT, Jojoba Esters, Trideceth-6

Questions or Comments?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 198 mL Bottle Label

Neutrogena®

#1 DERMATOLOGIST RECOMMENDED BRAND

Beach
Defense®

water + sun
protection

sunscreen lotion
BROAD SPECTRUM SPF 30

30

helioplex®
broad spectrum uvauvb

oxybenzone free

water resistant (80 minutes)

6.5 FL OZ (198 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF30 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0559
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	25 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	60 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	45 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Styrene/Acrylamide Copolymer (500000 MW) (UNII: 5Z4DPO246A)
Benzyl Alcohol (UNII: LKG8494WBH)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Dimethicone (UNII: 92RU3N3Y1O)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
DOCOSANOL (UNII: 9G1OE216XY)
Xanthan Gum (UNII: TTV12P4NEE)
Chlorphenesin (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Trideceth-6 (UNII: 3T5PCR2H0C)
Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L)
Hydrogenated Jojoba Oil/Jojoba Oil, Randomized (Iodine value 40-44) (UNII: AS2SZ9757N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0559-7	198 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/07/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)