AVEENO ULTRA-CALMING DAILY MOISTURIZER BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate lotion 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aveeno® Ultra Calming Daily Moisturizer Broad Spectrum SPF 15

Drug Facts

Active ingredientsPurpose
Avobenzone (3%)Sunscreen
Octinoxate (7.5%)Sunscreen
Octisalate (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 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, Cyclopentasiloxane, Glycerin, Arachidyl Alcohol, Phenyl Trimethicone, Phenoxyethanol, Cyclohexasiloxane, Cetearyl Glucoside, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Sodium Cocoyl Amino Acids, Polyacrylamide, Fragrance, Steareth-21, Arachidyl Glucoside, Disodium EDTA, Methylparaben, C13-14 Isoparaffin, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sarcosine, Laureth-7, Potassium Aspartate, Magnesium Aspartate

Questions?

Call toll-free 866-4AVEENO (866-428-3366) or 215-273-8755 (collect) or visit www.aveeno.com

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Aveeno®

ultra-
calming

daily
moisturizer
with
sunscreen
BROAD SPECTRUM
SPF15
for sensitive skin

Clinically proven to visibly
reduce the appearance
of redness in1 week

with Calming Feverfew®

4.0 fl. oz. (120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
AVEENO ULTRA-CALMING DAILY MOISTURIZER BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0374
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Dimethicone (UNII: 92RU3N3Y1O)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Panthenol (UNII: WV9CM0O67Z)  
Acrylic Acid/Ethylene Copolymer (600 MPA.S) (UNII: 1PEZ3NLY6I)  
Steareth-2 (UNII: V56DFE46J5)  
Docosanol (UNII: 9G1OE216XY)  
Steareth-21 (UNII: 53J3F32P58)  
Xanthan Gum (UNII: TTV12P4NEE)  
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
Aluminum Oxide (UNII: LMI26O6933)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
Methylparaben (UNII: A2I8C7HI9T)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Feverfew (UNII: Z64FK7P217)  
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)  
Sarcosine (UNII: Z711V88R5F)  
Laureth-7 (UNII: Z95S6G8201)  
Potassium Aspartate (UNII: OC4598NZEQ)  
Magnesium Aspartate (UNII: R17X820ROL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0374-41 in 1 CARTON02/01/201801/21/2022
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201801/21/2022
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: 9e2d7428-9497-47cc-8649-e0c79c5eb7b1
Set id: 72006065-3a14-4aba-bca4-e55155d8904f
Version: 2
Effective Time: 20190123
 
Johnson & Johnson Consumer Inc.