AVEENO ACTIVE NATURALS ULTRA-CALMING DAILY MOISTURIZER BROAD SPECTRUM SPF15- 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® Active Naturals® ultra-calming daily moisturizer with sunscreen BROAD SPECTRUM SPF 15

Drug Facts

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Purpose

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 Alchol, Panthenol, Ethylene/Acrylic Acid Copolymer, Sodium Cocoyl Amino Acids, Behenyl Alcohol, Steareth-2, Steareth-21, Fragrance, Polyacrylamide, Arachidyl Glocoside, Disodium EDTA, Methylparaben, C13-14 Isoparaffin, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, C12-16 Alkyl PEG-2 Hydroxypropyl Hydroxyethyl Ethylcellulose, Propylparaben, Sarcosine, Ethylparaben, Laureth-7, Iodopropynyl Butylcarbamate, Potassium Aspartate, Magnesium Aspartate

Questions?

Call toll-free 1-866-4AVEENO (866-428-3366) or 215-273-8755 (collect) or visit www.aveeno.com

Distributed by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS
COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

new formula
Aveeno®
ACTIVE NATURALS®

ultra-
calming

daily
moisturizer
with
sunscreen
BROAD SPECTUM
SPF 15

clinically proven
to calm and soothe
irritated, sensitive skin

ACTIVE NATURALS®
CALMING
FEVERFEW

4.0 fl. oz. (120 mL)

Principal Display Panel - 120 mL Bottle Carton
AVEENO ACTIVE NATURALS ULTRA-CALMING DAILY MOISTURIZER BROAD SPECTRUM SPF15 
avobenzone, octinoxate, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-9929
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)  
Docosanol (UNII: 9G1OE216XY)  
Steareth-2 (UNII: V56DFE46J5)  
Steareth-21 (UNII: 53J3F32P58)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Edetate Disodium (UNII: 7FLD91C86K)  
Methylparaben (UNII: A2I8C7HI9T)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Feverfew (UNII: Z64FK7P217)  
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sarcosine (UNII: Z711V88R5F)  
Ethylparaben (UNII: 14255EXE39)  
Laureth-7 (UNII: Z95S6G8201)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Potassium Aspartate (UNII: OC4598NZEQ)  
Magnesium Aspartate (UNII: R17X820ROL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-9929-41 in 1 CARTON11/16/201507/15/2020
1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/16/201507/15/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 6/2020
Document Id: 64a39ec0-4b69-436a-bab3-67d16b211735
Set id: 6694dfdd-1537-4195-aaae-0be77da68e18
Version: 3
Effective Time: 20200611
 
Johnson & Johnson Consumer Inc.