AVEENO NATURAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide cream

Aveeno Natural Protection Sunscreen by

Drug Labeling and Warnings

Aveeno Natural Protection Sunscreen by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide (6%)
Zinc Oxide (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: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
  • 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, Cetyl Dimethicone, Styrene/Acrylates Copolymer, PEG-8, Beeswax, Dimethylimidazolidinone Rice Starch, Polyamide-5, Butylene Glycol, Ethylhexylglycerin, Glyceryl Stearate, PEG-100 Stearate, Benzyl Alcohol, Dimethicone, Polyhydroxystearic Acid, Arachidyl Alcohol, Caprylyl Glycol, Trisiloxane, Dipropylene Glycol Dibenzoate, Glycerin, Pentylene Glycol, Behenyl Alcohol, Triethoxycaprylylsilane, Xanthan Gum, Citric Acid, Bisabolol, Acrylates/Dimethicone Copolymer, Arachidyl Glucoside, PPG-15 Stearyl Ether Benzoate, Chlorphenesin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Dipotassium Glycyrrhizate, Polyaminopropyl Biguanide, Sodium Citrate, Hydroxyphenyl Propamidobenzoic Acid, Polysorbate 60, Avena Sativa (Oat) Kernel Extract

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

new
Aveeno®
ACTIVE NATURALS®

natural
protection
100% naturally sourced
sunscreen ingredients

lotion

sunscreen

BROAD
SPECTRUM
SPF 50

for sensitive skin
fragrance free

with soothing oat

sweat + water
resistant (80 min)

DERMATOLOGIST
RECOMMENDED

NET WT. 3 OZ. (85 g)

INGREDIENTS AND APPEARANCE

AVEENO NATURAL PROTECTION SUNSCREEN   BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0806
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Yellow Wax (UNII: 2ZA36H0S2V)
DIMETHYLIMIDAZOLIDINONE RICE STARCH (UNII: 43YT4X3R70)
Butylene Glycol (UNII: 3XUS85K0RA)
Ethylhexylglycerin (UNII: 147D247K3P)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Benzyl Alcohol (UNII: LKG8494WBH)
Dimethicone (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Caprylyl Glycol (UNII: 00YIU5438U)
Trisiloxane (UNII: 9G1ZW13R0G)
Dipropylene Glycol Dibenzoate (UNII: 6OA5ZDY41O)
Glycerin (UNII: PDC6A3C0OX)
Pentylene Glycol (UNII: 50C1307PZG)
Docosanol (UNII: 9G1OE216XY)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Xanthan Gum (UNII: TTV12P4NEE)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Levomenol (UNII: 24WE03BX2T)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
PPG-15 Stearyl Ether Benzoate (UNII: 80D2J6361M)
Chlorphenesin (UNII: I670DAL4SZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
Squalane (UNII: GW89575KF9)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
POLIHEXANIDE (UNII: 322U039GMF)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)
Polysorbate 60 (UNII: CAL22UVI4M)
Oat (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0806-3	85 g in 1 TUBE; Type 0: Not a Combination Product	04/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/13/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)