AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM SPF30 - avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 4%, 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 and evenly 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, Glycerin, Silica, Cetyl Dimethicone, Dimethicone, Ethylhexylglycerin, Beeswax, Benzyl Alcohol Glyceryl Stearate, PEG-100 Stearate, Behenyl Alcohol, Phenoxyethanol, Caprylyl Glycol, Caprylyl Methicone, Acrylates/Dimethicone Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Chlorphenesin, Arachidyl Alcohol, Disodium EDTA, Diethylhexyl 2,6-Naphthalate, Sodium Hydroxide, Stearyl Alcohol, Fragrance, Avena Sativa (Oat) Kernel Flour, Cetyl Alcohol, Lignoceryl Alcohol, Avena Sativa (Oat) Kernel Extract, Codium Tomentosum Extract, Potassium Palmitoyl Hydrolyzed Oat Protein, Hydrolyzed Oat Protein

Questions?

866-AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

new
Aveeno®
ACTIVE NATURALS®

protect +
hydrate™
lotion

sunscreen

BROAD
SPECTRUM
SPF 30

helps reverse skin
dehydration

with nourishing oat

sweat + water
resistant (80 min)

DERMATOLOGIST
RECOMMENDED

NET WT. 3 OZ. (85 g)

Principal Display Panel - 85 g Tube Label

AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-0804
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (Avobenzone)	Avobenzone	30 mg in 1 g
Homosalate (Homosalate)	Homosalate	80 mg in 1 g
Octisalate (Octisalate)	Octisalate	40 mg in 1 g
Octocrylene (Octocrylene)	Octocrylene	40 mg in 1 g
Oxybenzone (Oxybenzone)	Oxybenzone	50 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water
Glycerin
Silicon Dioxide
Dimethicone
Ethylhexylglycerin
Yellow Wax
Benzyl Alcohol
Glyceryl Monostearate
PEG-100 Stearate
Docosanol
Phenoxyethanol
Caprylyl Glycol
Propylene Glycol
Chlorphenesin
Arachidyl Alcohol
Edetate Disodium
Diethylhexyl 2,6-Naphthalate
Sodium Hydroxide
Stearyl Alcohol
Oatmeal
Cetyl Alcohol
1-Tetracosanol
Oat
Codium Tomentosum

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:58232-0804-3	85 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/13/2012

Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 04/2012 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.