AVEENO BABY CONTINUOUS PROTECTION  SUNSCREEN BROAD SPECTRUM SPF55- 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 Baby Continuous Protection Sunscreen Broad Spectrum SPF55

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (10%), (Octisalate (5%), Octocrylene (2.8%), 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 15 minutes before sun exposure
  • reapply: - after 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, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Silica, Diethylhexyl 2,6-Naphthalate,VP/Hexadecene Copolymer, ,Dimethicone, Phenoxyethanol, ,Avena Sativa (Oat) Kernel Flour,Ethylhexylglycerin, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Trimethylsiloxysilicate,Sodium Polyacrylate, Ethylhexyl Stearate, Methylparaben, Behenyl Alcohol, Xanthan Gum,Propylparaben, Ethylparaben, Disodium EDTA, BHT, Trideceth-6

Questions?

1- 866-4AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 112 g Tube Label

Aveeno®
Baby®

continuous
protection®
lotion
sunscreen

BROAD
SPECTRUM
SPF 55

mild as water
fragrance free
with soothing oatmeal
sweat + water
resistant (80 min)

55

PEDIATRICIAN
RECOMMENDED

NET WT. 4 OZ. (112 g)

PRINCIPAL DISPLAY PANEL - 112 g Tube Label
AVEENO BABY CONTINUOUS PROTECTION   SUNSCREEN BROAD SPECTRUM SPF55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0626
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) Octocrylene28 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Diethylhexyl 2,6-naphthalate (UNII: I0DQJ7YGXM)  
Dimethicone (UNII: 92RU3N3Y1O)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Oatmeal (UNII: 8PI54V663Y)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
Methylparaben (UNII: A2I8C7HI9T)  
Docosanol (UNII: 9G1OE216XY)  
Xanthan Gum (UNII: TTV12P4NEE)  
Propylparaben (UNII: Z8IX2SC1OH)  
Ethylparaben (UNII: 14255EXE39)  
Edetate Disodium (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Trideceth-6 (UNII: 3T5PCR2H0C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-0626-1112 g in 1 TUBE; Type 0: Not a Combination Product02/01/200711/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/200711/04/2017
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 5/2020
Document Id: dd18bd3f-d197-4800-b9a7-a99701e21f66
Set id: 9e8821a5-5a09-4373-847d-634c5af1dcec
Version: 4
Effective Time: 20200506
 
Johnson & Johnson Consumer Inc.