AVEENO ACTIVE NATURALS ULTRA-CALMING DAILY MOISTURIZER BROAD SPECTRUM SPF15- avobenzone, octinoxate, and octisalate lotion

Aveeno Active Naturals Ultra-Calming Daily Moisturizer Broad Spectrum SPF15 by

Drug Labeling and Warnings

Aveeno Active Naturals Ultra-Calming Daily Moisturizer Broad Spectrum SPF15 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%, Octinoxate 7.5%, Octisalate 2%

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 generously 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, Cetearyl Alcohol, Dimethicone, Cyclopentasiloxane, Glycerin, Arachidyl Alcohol, Phenyl Trimethicone, Phenoxyethanol, Cyclohexasiloxane, Cetearyl Glucoside, Benzyl Alchol, Panthenol, Ethylene/Acrylic Acid Copolymer, Sodium Cocoyl Amino Acids, Behenyl Alcohol, Steareth-2, Steareth-21, Fragrance, Polyacrylamide, Arachidyl Glocoside, Disodium EDTA, Methylparaben, C13-14 Isoparaffin, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, C12-16 Alkyl PEG-2 Hydroxypropyl Hydroxyethyl Ethylcellulose, Propylparaben, Sarcosine, Ethylparaben, Laureth-7, Iodopropynyl Butylcarbamate, Potassium Aspartate, Magnesium Aspartate

Questions?

Call toll-free 1-866-4AVEENO (866-428-3366) or 215-273-8755 (collect) or visit www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

new formula
Aveeno®
ACTIVE NATURALS®

ultra-
calming

daily
moisturizer
with
sunscreen
BROAD SPECTUM
SPF 15

clinically proven
to calm and soothe
irritated, sensitive skin

ACTIVE NATURALS®
CALMING
FEVERFEW

4.0 fl. oz. (120 mL)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS ULTRA-CALMING DAILY MOISTURIZER BROAD SPECTRUM SPF15 
avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-9929
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
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Dimethicone (UNII: 92RU3N3Y1O)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Glycerin (UNII: PDC6A3C0OX)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Benzyl Alcohol (UNII: LKG8494WBH)
Panthenol (UNII: WV9CM0O67Z)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Steareth-21 (UNII: 53J3F32P58)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Edetate Disodium (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Feverfew (UNII: Z64FK7P217)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Propylparaben (UNII: Z8IX2SC1OH)
Sarcosine (UNII: Z711V88R5F)
Ethylparaben (UNII: 14255EXE39)
Laureth-7 (UNII: Z95S6G8201)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Potassium Aspartate (UNII: OC4598NZEQ)
Magnesium Aspartate (UNII: R17X820ROL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-9929-4	1 in 1 CARTON	11/16/2015
1		120 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	11/16/2015

Labeler - Johnson & Johnson Consumer Inc. (002347102)