AVEENO ACTIVE NATURALS SMART ESSENTIALS DAILY NOURISHING MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Aveeno Active Naturals Smart Essentials Daily Nourishing Moisturizer by

Drug Labeling and Warnings

Aveeno Active Naturals Smart Essentials Daily Nourishing Moisturizer by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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, Octyldodecyl Neopentanoate, Glycerin, Butylene Glycol, Cetyl Alcohol, Potassium Cetyl Phosphate, Phenoxyethanol, Silica, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glyceryl Stearate, Microcrystalline Cellulose, Fragrance, Hydrolyzed Caesalpinia Spinosa Gum, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Magnesium Aluminum Silicate, Chlorphenesin, Sodium PCA, Urea, Cetyl Hydroxyethylcellulose, Artemisia Abrotanum Extract, Panthenol, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Disodium EDTA, Ethylhexylglycerin, Caesalpinia Spinosa Gum, Trehalose, Cellulose Gum, Polyquaternium-51, Triacetin, Sodium Hyaluronate, Sodium Hydroxide, Citric Acid

Questions?

866-4AVEENO (866-428-3366); or 215-273-8755 or visit www.aveeno.com

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Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

Aveeno®
ACTIVE NATURALS®

smart
essentials®

daily nourishing
moisturizer
with
sunscreen
BROAD SPECTRUM
SPF 30

vitamins A, C & E
protect what
you love

ACTIVE NATURALS®
SOUTHERNWOOD

2.5 fl. oz. (74 mL)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS SMART ESSENTIALS DAILY NOURISHING MOISTURIZER   SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0214
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)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
Cetyl Alcohol (UNII: 936JST6JCN)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Phenoxyethanol (UNII: HIE492ZZ3T)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Chlorphenesin (UNII: I670DAL4SZ)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Urea (UNII: 8W8T17847W)
Edetate Disodium (UNII: 7FLD91C86K)
Panthenol (UNII: WV9CM0O67Z)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
Ethylhexylglycerin (UNII: 147D247K3P)
Caesalpinia Spinosa Resin (UNII: WL3883U2PO)
Trehalose (UNII: B8WCK70T7I)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Triacetin (UNII: XHX3C3X673)
Sodium Hydroxide (UNII: 55X04QC32I)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Hyaluronate Sodium (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0214-2	1 in 1 CARTON	11/01/2010
1		74 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)