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Aveeno

Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

Aveeno Ultra Calming Daily Moisturizer SPF 30


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Homosalate (5%)................................................................... Sunscreen
Octinoxate (7.5%).................................................................. Sunscreen
Octisalate (5%)...................................................................... Sunscreen
Titanium Dioxide (2.3)%......................................................... Sunscreen

Aveeno Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Provides high protection against sunburn

Warnings

For external use only

When using this product

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • Rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply evenly before sun exposure and as needed.
  • Children under 6 months of age; ask a doctor.

Other Information

For best results, use twice daily and in conjunction with Ultra-Calming Moisturizing Cream Cleanser. • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Alumina, Aluminum Stearate, Bisabolol, Butylene Glycol, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Tanacetum Parthenium (Feverfew) Leaf/Flower/Stem Juice, Glyceryl Stearate, Hexylene Glycol, Hydrogenated Palm Glycerides, Hydrogenated Palm Kernel Glycerides, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Isohexadecane, Magnesium Aluminum Silicate, Methylisothiazolinone, PEG-100 Stearate, Phenyl Trimethicone, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, PPG-3 Myristyl Ether Neoheptanoate, Silica, Tetrasodium EDTA, Triethylhexanoin, Water, Xanthan Gum

Questions?

1-866-4AVEENO or visit wwwaveeno.com

PRINCIPAL DISPLAY PANEL - 75 mL container

Aveeno®
ACTIVE NATURALS®

Ultra-Calming
DAILY MOISTURIZER

SPF 30
UVA/UVB sunscreen

fragrance-free

visibly reduces the
appearance of redness
and soothes sensitive skin

with naturally
calming feverfew

2.5 fl. oz. (75 mL)

Aveeno

Aveeno

Homosalate, Octinoxate, Octisalate and Titanium Dioxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58232-0512
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 51.3 mg
OCTINOXATE OCTINOXATE 76.9 mg
OCTISALATE OCTISALATE 51.3 mg
titanium dioxide 24.6 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 75 in 1 BOTTLE, PLASTIC
2 NDC:58232-0512-2 10 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-08-25


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