AVEENO ULTRA-CALMING DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide 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 sunscreen BROAD SPECTRUM SPF 30

Drug Facts

Active ingredientsPurpose
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

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, Cyclopentasiloxane, Glycerin, Styrene/Acrylates Copolymer, Isopropyl Myristate, Cetyl Dimethicone, Octyldodecyl Neopentanoate, Glyceryl Behenate, PEG-100 Stearate, Glyceryl Stearate, Benzyl Alcohol, Aluminum Stearate, Arachidyl Alcohol, Ethylhexylglycerin, Polyhydroxystearic Acid, Caprylyl Glycol, Behenyl Alcohol, Alumina, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Citric Acid, Methyldihydrojasmonate, Squalane, Arachidyl Glucoside, Dimethicone, Chlorphenesin, Triethoxycaprylylsilane, Dipropylene Glycol Dibenzoate, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, PPG-15 Stearyl Ether Benzoate, Acrylates/Dimethicone Copolymer, Sodium Citrate, Polysorbate 60, Alpha-Isomethyl Ionone (and) Methyl Ionones, Ceramide NP, Avena Sativa (Oat) Kernel Extract

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 68 mL Bottle Carton

DERMATOLOGIST RECOMMENDED
Aveeno®
ULTRA-
CALMING

100%
Mineral

daily
moisturizer
sunscreen

BROAD SPECTRUM
SPF30
fragrance free

instantly calms
sensitive,
dry skin

CALMING
FEVERFEW ®
2.3 fl oz (68 mL)

PRINCIPAL DISPLAY PANEL - 68 mL Bottle Carton
AVEENO ULTRA-CALMING DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0387
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE43 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
METHYL IONONES (UNII: EL78BGX1LO)  
CERAMIDE NP (UNII: 4370DF050B)  
OAT (UNII: Z6J799EAJK)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DOCOSANOL (UNII: 9G1OE216XY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
SQUALANE (UNII: GW89575KF9)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
FEVERFEW (UNII: Z64FK7P217)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0387-21 in 1 CARTON11/01/201701/03/2023
168 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69968-0387-18 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201704/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201701/03/2023
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 3/2022
Document Id: d9eb768a-3076-32b1-e053-2a95a90aa41a
Set id: 0d4f04e9-64b5-4c52-8924-8510155f02d7
Version: 4
Effective Time: 20220311
 
Johnson & Johnson Consumer Inc.