AVEENO FAVORITES FROM POSITIVELY RADIANT- avobenzone, octinoxate, and octisalate kit

Aveeno favorites from Positively radiant by

Drug Labeling and Warnings

Aveeno favorites from Positively radiant 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%, 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, 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?

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 INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Carton

SPECIAL
VALUE
FULL SIZE
products inside

AVEENO ®
favorites
from positively radiant®
1 week to healthier looking and more radiant skin

skin
brightening
daily scrub

CLEANSE
to help even
skin tone
and texture

net wt.5.0 oz. (140 g)

daily
moisturizer
with
sunscreen
BROAD SPECTRUM
SPF 15

MOISTURIZE
to help improve
the look of
brown spots

4.0 fl.oz. (120mL)

INGREDIENTS AND APPEARANCE

AVEENO FAVORITES FROM POSITIVELY RADIANT 
avobenzone, octinoxate, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0222

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0222-9	1 in 1 CARTON	04/22/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	140 g
Part 2	1 BOTTLE, PUMP	120 mL

Part 1 of 2

AVEENO ACTIVE NATURALS POSITIVELY RADIANT SKIN BRIGHTENING DAILY SCRUB  
cleansing (cold creams, cleansing lotions, liquids, and pads) suspension

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
INGR	Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
INGR	Lauryl Glucoside (UNII: 76LN7P7UCU)
INGR	Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Glycol Distearate (UNII: 13W7MDN21W)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Hydrogenated Jojoba Oil (UNII: 7F674YQ5SO)
INGR	Laureth-4 (UNII: 6HQ855798J)
INGR	Edetate Sodium (UNII: MP1J8420LU)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Soy Protein (UNII: R44IWB3RN5)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		140 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		11/01/2015

Part 2 of 2

AVEENO POSITIVELY RADIANT DAILY MOISTURIZER   BROAD SPECTRUM SPF15
avobenzone, octinoxate, and octisalate lotion

Product Information
Item Code (Source)	NDC: 58232-9930
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)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Phenoxyethanol (UNII: HIE492ZZ3T)
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)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Edetate Disodium (UNII: 7FLD91C86K)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Laureth-7 (UNII: Z95S6G8201)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Sodium Hydroxide (UNII: 55X04QC32I)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Titanium Dioxide (UNII: 15FIX9V2JP)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-9930-4	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	11/13/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/22/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)