AVEENO ACTIVE NATURALS POSITIVELY RADIANT DAILY MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Aveeno Active Naturals Positively Radiant Daily Moisturizer with sunscreen by

Drug Labeling and Warnings

Aveeno Active Naturals Positively Radiant Daily Moisturizer with sunscreen 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 (12%), Octisalate (5%), Octocrylene (1.7%), Oxybenzone (3%)

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

For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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, C12-15 Alkyl Benzoate, Dimethicone, Cetearyl Alcohol, Glycine Soja (Soybean) Seed Extract, Diethylhexyl 2,6-Naphthalate, Glycerin, Ethylene/Acrylic Acid Copolymer, Phenoxyethanol Phenyl Trimethicone, Silica, Panthenol, Arachidyl Alcohol, Aluminum Starch Octenylsuccinate, Cetearyl Glucoside, Methylparaben, Steareth-2, Fragrance, Polyacrylate-13, Behenyl Alcohol, Steareth-21, Polymethyl Methacrylate, Disodium EDTA, Polyisobutene, Arachidyl Glucoside, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Propylparaben, Ethylparaben, Benzalkonium Chloride, Polysorbate 20, Boron Nitride, Titanium Dioxide, Mica

Questions?

866-4AVEENO (866-428-3366); Outside US, dial collect 215-273-8755; or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

Aveeno®
ACTIVE NATURALS®
positively
radiant®

5
FACTORS
OF RADIANCE™

daily
moisturizer
with
sunscreen
BROAD SPECTRUM
SPF 30

clinically proven
to even tone
and texture

ACTIVE NATURALS®
TOTAL SOY
COMPLEX

2.5 fl. oz. (75 mL)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS POSITIVELY RADIANT DAILY MOISTURIZER WITH SUNSCREEN   BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0603
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	120 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	17 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Soybean (UNII: L7HT8F1ZOD)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Glycerin (UNII: PDC6A3C0OX)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Panthenol (UNII: WV9CM0O67Z)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Methylparaben (UNII: A2I8C7HI9T)
Steareth-2 (UNII: V56DFE46J5)
Docosanol (UNII: 9G1OE216XY)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Propylparaben (UNII: Z8IX2SC1OH)
Ethylparaben (UNII: 14255EXE39)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Polysorbate 20 (UNII: 7T1F30V5YH)
Boron Nitride (UNII: 2U4T60A6YD)
Titanium Dioxide (UNII: 15FIX9V2JP)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0603-1	1 in 1 CARTON	01/01/2006
1		75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 58232-0603-2	9 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2006

Labeler - Johnson & Johnson Consumer Inc. (002347102)