AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 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 ® Protect + Hydrate Lotion Sunscreen Broad Spectrum SPF 70

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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, Styrene/Acrylates Copolymer, Silica, Dimethicone, Benzyl Alcohol, Glycerin, Ethylhexylglycerin, Glyceryl Stearate, PEG-100 Stearate, Beeswax, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Phenoxyethanol, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Propylene Glycol, Sodium Hydroxide, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Fragrance, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Extract, Codium Tomentosum Extract, Hydrolyzed Oat Protein, Potassium Palmitoyl Hydrolyzed Oat Protein

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 - 198 g Tube Label

DERMATOLOGIST
RECOMMENDED
Aveeno ®

PROTECT +
HYDRATE

sunscreen

BROAD SPECTRUM SPF 70

with antioxidant oat

all-day hydration

sweat + water resistant
 (80 min)

SPF
70

net wt. 7 OZ. (198 g)

PRINCIPAL DISPLAY PANEL - 198 g Tube Label
AVEENO PROTECT PLUS HYDRATE  SUNSCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0393
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) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DOCOSANOL (UNII: 9G1OE216XY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
OATMEAL (UNII: 8PI54V663Y)  
OAT (UNII: Z6J799EAJK)  
CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0393-7198 g in 1 TUBE; Type 0: Not a Combination Product10/01/201802/03/2023
2NDC:69968-0393-385 g in 1 TUBE; Type 0: Not a Combination Product10/01/201801/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/201802/03/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023
 
Johnson & Johnson Consumer Inc.