AVEENO ACTIVE NATURALS DAILY MOISTURIZING BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene, and oxybenzone lotion

Aveeno Active Naturals Daily Moisturizing by

Drug Labeling and Warnings

Aveeno Active Naturals Daily Moisturizing 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 5%
Octisalate 1.7%
Octocrylene 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

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

Questions?

1-866-AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

dermatologist
recommended

Aveeno®
ACTIVE NATURALS®

Daily Moisturizing
LOTION

with
sunscreen
BROAD SPECTRUM
SPF 15

clinically shown to
moisturize for 24 hours

non-greasy

with
natural colloidal oatmeal

12 fl. oz. (354 mL)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS DAILY MOISTURIZING   BROAD SPECTRUM SPF15
avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0125
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
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)
Glycerin (UNII: PDC6A3C0OX)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetyl Alcohol (UNII: 936JST6JCN)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Dimethicone (UNII: 92RU3N3Y1O)
Oatmeal (UNII: 8PI54V663Y)
Methylparaben (UNII: A2I8C7HI9T)
Steareth-21 (UNII: 53J3F32P58)
Edetate Disodium (UNII: 7FLD91C86K)
Benzalkonium Chloride (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0125-1	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2007	12/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2007	12/06/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)