AVEENO POSITIVELY RADIANT CC BROAD SPECTRUM SPF30 - MEDIUM- homosalate, octinoxate, octisalate, and oxybenzone lotion

Aveeno Positively Radiant CC by

Drug Labeling and Warnings

Aveeno Positively Radiant CC 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 INGREDIENT

Active Ingredients	Purpose
Homosalate (5%)	Sunscreen
Octinoxate (7.5%)	Sunscreen
Octisalate (5%)	Sunscreen
Oxybenzone (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 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, Phenyl Trimethicone, PPG-3 Myristyl Ether, Glycine Soja (Soybean) Seed Extract, Butylene Glycol, Hydrogenated Palm Kernel Glycerides, Silica, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Glycerin, PPG-3 Myristyl Ether Neoheptanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Isohexadecane, Bisabolol, Fragrance, Citric Acid, Magnesium Aluminum Silicate, Cetearyl Glucoside, p-Anisic Acid, Polysorbate 20, Sodium C14-16 Olefin Sulfonate, Hydrogenated Palm Glycerides, Sodium PCA, Urea, Cetyl Hydroxyethylcellulose, Polysorbate 60, Tetrasodium EDTA, Xanthan Gum, Hexylene Glycol, Trehalose, Polyquaternium-51, Methylisothiazolinone, Triacetin, Sodium Hyaluronate, Titanium Dioxide, Iron Oxides, Mica

Questions or comments?

Call toll-free 866-4AVEENO (866-428-3366) or 215-273-8755 (collect) or visit us at 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

new
Aveeno®
ACTIVE NATURALS®

positively
radiant®

CC
CREAM

5
FACTORS
OF RADIANCE®

CC Cream
with
sunscreen
BROAD SPECTRUM
SPF 30

medium
tinted moisturizer

color corrects,
protects, and perfects

ACTIVE NATURALS®
TOTAL SOY
COMPLEX

2.5 fl. oz. (75 mL)

INGREDIENTS AND APPEARANCE

AVEENO POSITIVELY RADIANT CC   BROAD SPECTRUM SPF30 - MEDIUM
homosalate, octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
PPG-3 Myristyl Ether (UNII: 7913J43WZ5)
Soybean (UNII: L7HT8F1ZOD)
Butylene Glycol (UNII: 3XUS85K0RA)
Hydrogenated Palm Kernel Glycerides (UNII: UM8Y22J4JW)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glycerin (UNII: PDC6A3C0OX)
Caprylyl Glycol (UNII: 00YIU5438U)
Isohexadecane (UNII: 918X1OUF1E)
Levomenol (UNII: 24WE03BX2T)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Cetearyl Glucoside (UNII: 09FUA47KNA)
p-Anisic Acid (UNII: 4SB6Y7DMM3)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Urea (UNII: 8W8T17847W)
Polysorbate 60 (UNII: CAL22UVI4M)
Edetate Sodium (UNII: MP1J8420LU)
Xanthan Gum (UNII: TTV12P4NEE)
Hexylene Glycol (UNII: KEH0A3F75J)
Trehalose (UNII: B8WCK70T7I)
Methylisothiazolinone (UNII: 229D0E1QFA)
Triacetin (UNII: XHX3C3X673)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0001-1	1 in 1 CARTON	06/01/2014
1		75 mL in 1 BOTTLE; 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	06/01/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)