NEUTROGENA WET SKIN KIDS BEACH AND POOL SUNSCREEN BROAD SPECTRUM SPF45 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Wet Skin Kids Beach and Pool by

Drug Labeling and Warnings

Neutrogena Wet Skin Kids Beach and Pool by is a Otc medication manufactured, distributed, or labeled by Neutrogena Corporation, Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

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

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 age: Ask a doctor

Other information

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Beeswax, Benzyl Alcohol, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chlorphenesin, Diethylhexyl 2,6-Naphthalate, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethyl Methicone, Ethylhexylglycerin, Fragrance, Glyceryl Behenate, Glyceryl Dibehenate, Glyceryl Stearate, Nelumbo Nucifera Flower Wax, Octyldodecyl Citrate Crosspolymer, Oryza Sativa (Rice) Starch, PEG-100 Stearate, Phenoxyethanol, Silica, Tribehenin, Triethanolamine, Water

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 Corporation,
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

NEW

Neutrogena®

wet skin

kids

BEACH & POOL

SUNSCREEN

Broad
Spectrum
SPF 45+

helioplex®
broad spectrum uvauvb

full strength protection
on wet or dry skin
hypoallergenic
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA WET SKIN KIDS BEACH AND POOL   SUNSCREEN BROAD SPECTRUM SPF45 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-528
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	40 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	40 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Yellow Wax (UNII: 2ZA36H0S2V)
Benzyl Alcohol (UNII: LKG8494WBH)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Dimethicone (UNII: 92RU3N3Y1O)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Edetate Disodium (UNII: 7FLD91C86K)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
Ethylhexylglycerin (UNII: 147D247K3P)
Glyceryl Dibehenate (UNII: R8WTH25YS2)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Nelumbo Nucifera Flower Wax (UNII: U01S6C427I)
Starch, Rice (UNII: 4DGK8B7I3S)
PEG-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Tribehenin (UNII: 8OC9U7TQZ0)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-528-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	09/19/2012
2	NDC: 10812-528-02	29 mL in 1 TUBE; Type 0: Not a Combination Product	09/19/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/19/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)