AVEENO ACTIVE NATURALS NATURAL PROTECTION BROAD SPECTRUM SPF30- titanium dioxide and zinc oxide cream

Aveeno Active Naturals Natural Protection by

Drug Labeling and Warnings

Aveeno Active Naturals Natural Protection 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 INGREDIENT

• Active ingredients: Purpose
• Titanium Dioxide (4.3%): Sunscreen
• Zinc Oxide (3%): 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 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

Trisiloxane

Dimethicone

PEG-8

Beeswax

Dimethylimidazolidinone Rice Starch

Polyamide-5

Butylene Glycol

Ethylhexylglycerin

Glyceryl Stearate

PEG-100 Stearate

Benzyl Alcohol

Arachidyl Alcohol

Polyhydroxystearic Acid

Caprylyl Glycol

Glycerin

Pentylene Glycol

Behenyl Alcohol

Dipropylene Glycol Dibenzoate

Xanthan Gum

Triethoxycaprylylsilane

Citric Acid

Bisabolol

Acrylates/Dimethicone Copolymer

Arachidyl Glucoside

Chlorphenesin

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

PPG-15 Stearyl Ether Benzoate

Squalane

Dipotassium Glycyrrhizate

Polyaminopropyl Biguanide

Sodium Citrate

Hydroxyphenyl Propamidobenzoic Acid

Polysorbate 60

Avena Sativa (Oat) Kernel Extract

Questions?

866-4-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 look
Aveeno®
ACTIVE NATURALS®

natural
proection
100% naturally sourced
sunscreen ingredients
lotion
sunscreen
BROAD
SPECTRUM
SPF 30

for sensitive skin
fragrance free
with skin soothing oat
sweat + water
resistant (80 min)

DERMATOLOGIST
RECOMMENDED
NET WT. 3 OZ. (85 g)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS NATURAL PROTECTION   BROAD SPECTRUM SPF30
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	43 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)
Trisiloxane (UNII: 9G1ZW13R0G)
Dimethicone (UNII: 92RU3N3Y1O)
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)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Caprylyl Glycol (UNII: 00YIU5438U)
Glycerin (UNII: PDC6A3C0OX)
Pentylene Glycol (UNII: 50C1307PZG)
Docosanol (UNII: 9G1OE216XY)
Dipropylene Glycol Dibenzoate (UNII: 6OA5ZDY41O)
Xanthan Gum (UNII: TTV12P4NEE)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Levomenol (UNII: 24WE03BX2T)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Chlorphenesin (UNII: I670DAL4SZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
Squalane (UNII: GW89575KF9)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Polyaminopropyl Biguanide (UNII: DT9D8Z79ET)
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: 58232-0040-1	85 g in 1 TUBE; Type 0: Not a Combination Product	01/10/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/10/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)