AVEENO DAILY MOISTURIZING SPF15 - avobenzone, octisalate, octocrylene and oxybenzone 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
Octisalate	5%	Sunscreen
Octocrylene	1.7%	Sunscreen
Oxybenzone	3%	Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection
Provides moderate protection against sunburn and tanning
For skin that sunburns easily

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.

Inactive ingredients

Avena Sativa (Oat) Kernel Flour, Benzalkonium Chloride, C12-15 Alkyl Benzoate, Cetyl Alcohol, Diethylhexyl 2,6-Naphthalate, Dimethicone, Disodium EDTA, Distearyldimonium Chloride, Glycerin, Methylparaben, Steareth-21, Water

Questions?

Call 1-866-428-3366 or visit www.aveeno.com

Distributed by
Johnson & Johnson
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

dermatologist
recommended

Aveeno®
Active Naturals®

Daily Moisturizing
LOTION WITH SUNSCREEN

active
photobarrier
complex™
SPF
15

uva/uvb protection

clinically shown to
moisturize for 24 hours

non-greasy

with
natural colloidal oatmeal

12 fl. oz. (354 mL)

Principal Display Panel - 354 mL Bottle Label

AVEENO DAILY MOISTURIZING SPF15
avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-0716
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (Avobenzone)	Avobenzone	30 mg in 1 mL
Octisalate (Octisalate)	Octisalate	50 mg in 1 mL
Octocrylene (Octocrylene)	Octocrylene	17 mg in 1 mL
Oxybenzone (Oxybenzone)	Oxybenzone	30 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Oatmeal
Benzalkonium Chloride
Alkyl (C12-15) Benzoate
Cetyl Alcohol
Diethylhexyl 2,6-Naphthalate
Dimethicone
Edetate Disodium
Distearyldimonium Chloride
Glycerin
Methylparaben
Steareth-21
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:58232-0716-2	354 mL in 1 BOTTLE, PUMP	None
2	NDC:58232-0716-3	45 mL in 1 TUBE	None
3	NDC:58232-0716-1	240 mL in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/12/2011

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

Revised: 08/2011 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.