AVEENO ACTIVE NATURALS PROTECT PLUS HYDRATE SUNSCREEN  BROAD SPECTRUM SPF50 FOR FACE- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream 
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® protect+hydrate lotion sunscreen BROAD SPECTRUM SPF 50 FOR FACE

Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 6%
Oxybenzone 5%

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

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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, Glycerin, Silica, Cetyl Dimethicone, Dimethicone, Beeswax, Benzyl Alcohol, Ethylhexylglycerin, Glyceryl Stearate, PEG-100 Stearate, Behenyl Alcohol, Phenoxyethanol, Caprylyl Methicone, Caprylyl Glycol, Acrylates/Dimethicone Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Chlorphensin, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Sodium Hydroxide, Fragrance, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Extract, Codium Tomentosum Extract, Hydrolyzed Oat Protein, Potassium Palmitoyl Hydrolyzed Oat Protein

Questions?

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

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

Aveeno®
ACTIVE NATURALS®

protect +
hydrate
lotion
sunscreen

BROAD
SPECTRUM
SPF 50
FOR FACE

oil-free
non-comedogenic

with nourishing oat

sweat + water
resistant (80 min)

DERMATOLOGIST
RECOMMENDED

NET WT. 3 OZ. (85g)

Principal Display Panel - 85 g Tube Label
AVEENO ACTIVE NATURALS PROTECT PLUS HYDRATE SUNSCREEN   BROAD SPECTRUM SPF50 FOR FACE
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene60 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Dimethicone (UNII: 92RU3N3Y1O)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Docosanol (UNII: 9G1OE216XY)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Chlorphenesin (UNII: I670DAL4SZ)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Edetate Disodium (UNII: 7FLD91C86K)  
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Oatmeal (UNII: 8PI54V663Y)  
Cetyl Alcohol (UNII: 936JST6JCN)  
1-Tetracosanol (UNII: 2N0PI37IOC)  
Oat (UNII: Z6J799EAJK)  
Codium Tomentosum (UNII: B8B45BRU87)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0048-385 g in 1 TUBE; Type 0: Not a Combination Product09/12/201205/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/12/201205/18/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019
 
Johnson & Johnson Consumer Inc.