AVEENO POSITIVELY AGELESS COMPLETE - avobenzone, octisalate, octocrylene, oxybenzone and homosalate lotion
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	Purpose
Avobenzone (3%)	Sunscreen
Homosalate (12%)	Sunscreen
Octisalate (5%)	Sunscreen
Octocrylene (1.7%)	Sunscreen
Oxybenzone (3)%	Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection
Provides high protection against sunburn
For skin highly sensitive to sunburn

Warnings

For external use only

When using this product

Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly before sun exposure and as needed.
Children under 6 months of age; ask a doctor.

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Store at room temperature.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Algae Extract, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Benzalkonium Chloride, Boron Nitride, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Cetearyl Alcohol, Cetearyl Glucoside, Cyclopentasiloxane, Diethylhexyl 2,6-Naphthalate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylene/Acrylic Acid Copolymer, Ethylparaben, Fragrance, Ganoderma Lucidum (Mushroom) Stem Extract, Glycerin, Hydrolyzed Wheat Protein, Laureth-7, Lentinus Edodes Extract (Shiitake Mushroom), Methylparaben, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Phenoxyethanol, Polyacrylamide, Propylparaben, Silica, Steareth-2, Steareth-21, Water

May also contain: Citric Acid, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL 30 mL Tube Label

Aveeno®
ACTIVE NATURALS™

new
clinically proven results

positively ageless™
complete anti-aging system

100% of women showed younger
looking skin in one week *

ACTIVE NATURALS®
NATURAL SHITAKE
COMPLEX

A Comprehensive Daily Regimen

Cleanser
3 fl oz (88mL)

Eye Cream
0.5 fl oz (15mL)

Daily Moisturizer
1 fl oz (30 mL)

Night Cream
1 fl oz (30 mL)

PRINCIPAL DISPLAY PANEL 30 mL Tube Label

AVEENO POSITIVELY AGELESS COMPLETE
avobenzone, octisalate, octocrylene, oxybenzone, and homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-0629
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (Avobenzone)	Avobenzone	31 mg in 1 mL
Octisalate (Octisalate)	Octisalate	52 mg in 1 mL
Octocrylene (Octocrylene)	Octocrylene	18 mg in 1 mL
Oxybenzone (Oxybenzone)	Oxybenzone	31 mg in 1 mL
Homosalate (Homosalate)	Homosalate	125 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Arachidyl Alcohol
Arachidyl Glucoside
Docosanol
Benzalkonium Chloride
Boron Nitride
Alkyl (C12-15) Benzoate
C13-14 Isoparaffin
Cetostearyl Alcohol
Cetearyl Glucoside
Cyclomethicone 5
Diethylhexyl 2,6-Naphthalate
Dimethicone
Edetate Disodium
Ethylparaben
Ganoderma Lucidum Stem
Glycerin
Laureth-7
Lentinula Edodes Mycelium
Methylparaben
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)
Phenoxyethanol
Propylparaben
Silicon Dioxide
Steareth-2
Steareth-21
Water
Citric Acid Monohydrate
Sodium Hydroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:58232-0629-9	1 TUBE in 1 KIT	contains a TUBE
1		30 mL in 1 TUBE	This package is contained within the KIT (58232-0629-9)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/10/2009	11/28/2012

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

Revised: 11/2012 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.