AVEENO POSITIVELY RADIANT TARGETED DARK SPOT CORRECTOR BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate cream

Aveeno positively radiant targeted dark spot corrector Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Aveeno positively radiant targeted dark spot corrector Broad Spectrum SPF 15 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 INGREDIENT

Active ingredients	Purpose
Avobenzone (3%)	Sunscreen
Octinoxate (7.5%)	Sunscreen
Octisalate (2%)	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, Glycine Soja (Soybean) Seed Extract, Phenyl Trimethicone, Glycerin, Arachidyl Alcohol, Cetearyl Glucoside, Phenoxyethanol, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Fragrance, Steareth-21, Polymethyl Methacrylate, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Laureth-7, Silica, Benzalkonium Chloride, Iodopropynyl Butylcarbamate, BHT, Sodium Hydroxide, Citric Acid, Titanium Dioxide, Mica

Questions or comments?

call toll-free 866-4AVEENO or 215-273-8755 (collect) www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

new

Aveeno®

ACTIVE NATURALS®

positively radiant®
targeted cream
dark spot corrector

with

sunscreen

Broad Spectrum SPF 15

clinically proven to
improve the look of
dark spots for more
visibly radiant
skin in 1 week

5
FACTORS
OF RADIANCE™

ACTIVE NATURALS®

TOTAL SOY

COMPLEX

2.0 Fl. Oz. (59 mL)

INGREDIENTS AND APPEARANCE

AVEENO POSITIVELY RADIANT TARGETED DARK SPOT CORRECTOR BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0341
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)
Soybean (UNII: L7HT8F1ZOD)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Glycerin (UNII: PDC6A3C0OX)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Pentylene Glycol (UNII: 50C1307PZG)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Phenoxyethanol (UNII: HIE492ZZ3T)
Steareth-21 (UNII: 53J3F32P58)
Benzyl Alcohol (UNII: LKG8494WBH)
Panthenol (UNII: WV9CM0O67Z)
Acrylic Acid/Ethylene Copolymer (600 MPA.S) (UNII: 1PEZ3NLY6I)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Laureth-7 (UNII: Z95S6G8201)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Titanium Dioxide (UNII: 15FIX9V2JP)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Mica (UNII: V8A1AW0880)
Benzalkonium Chloride (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0341-2	1 in 1 CARTON	11/01/2017
1		59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69968-0341-1	14 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/01/2017

Labeler - Johnson & Johnson Consumer Inc. (002347102)