Aveeno Ultra Calming Daily Moisturizer SPF 30

Drug Labeling and Warnings

Drug Details [pdf]

AVEENO  ULTRA-CALMING DAILY MOISTURIZER SPF 30- homosalate, octinoxate, octisalate and titanium dioxide 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.

----------

Aveeno Ultra Calming Daily Moisturizer SPF 30

Drug Facts

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

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)

Principal Display Panel - 75 mL container
AVEENO   ULTRA-CALMING DAILY MOISTURIZER SPF 30
homosalate, octinoxate, octisalate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58232-0512
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate51.3 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate76.9 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate51.3 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide24.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aluminum Oxide (UNII: LMI26O6933)  
Aluminum Stearate (UNII: U6XF9NP8HM)  
Levomenol (UNII: 24WE03BX2T)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Feverfew (UNII: Z64FK7P217)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
Hydrogenated Palm Kernel Glycerides (UNII: UM8Y22J4JW)  
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Isohexadecane (UNII: 918X1OUF1E)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
PEG-100 Stearate (UNII: YD01N1999R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Edetate Sodium (UNII: MP1J8420LU)  
Triethylhexanoin (UNII: 7K3W1BIU6K)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-0512-11 in 1 CARTON08/25/200908/31/2016
175 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 58232-0512-210 mL in 1 TUBE; Type 0: Not a Combination Product08/25/200908/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/25/200908/31/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2019