NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF70- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Beach Defense Water Plus Sun Protection by

Drug Labeling and Warnings

Neutrogena Beach Defense Water Plus Sun Protection 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 ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 4.5%
Oxybenzone 4%

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 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 value of SPF 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: Ask a doctor

Other information

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

Inactive Ingredients

Water, Styrene/Acrylates Copolymer, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Silica, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Trisiloxane, Cetyl Dimethicone, Beeswax, Ethylhexylglycerin, Sodium Polyacrylate, Xanthan Gum, Ethylhexyl Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol , Trideceth-6, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Chlorphenesin, Fragrance

Questions or comments?

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

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Dist. by Neutrogena Corp.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 198 mL Bottle Label

Neutrogena®

Beach
Defense®
water + sun
protection

SUNSCREEN LOTION
Broad Spectrum SPF70

70

helioplex®
broad spectrum uva-uvb

water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

6.7 FL OZ (198mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION   SUNSCREEN BROAD SPECTRUM SPF70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-416
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 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	45 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Benzyl Alcohol (UNII: LKG8494WBH)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Trisiloxane (UNII: 9G1ZW13R0G)
Yellow Wax (UNII: 2ZA36H0S2V)
Ethylhexylglycerin (UNII: 147D247K3P)
Xanthan Gum (UNII: TTV12P4NEE)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
Docosanol (UNII: 9G1OE216XY)
Trideceth-6 (UNII: 3T5PCR2H0C)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-416-01	198 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2012
2	NDC: 10812-416-02	29 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)