AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF50- 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 Baby ® CONTINUOUS PROTECTION ® sensitive skin sunscreen

BROAD SPECTRUM SPF 50

Drug Facts

Active Ingredient

Zinc Oxide 21.6%

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 liberally 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 value of SPF 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, C 12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Polyhydroxystearic Acid, Glycerin, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Avena Sativa (Oat) Kernel Flour, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew)Flower/Leaf/Stem Juice

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 - 207 mL Tube Label

PEDIATRICIAN
RECOMMENDED BRAND
Aveeno
Baby ®
CONTINUOUS
PROTECTION ®
sensitive skin
zinc oxide
sunscreen
BROAD SPECTRUM SPF 50
naturally-sourced 100%
mineral active ingredient
sweat + water resistant
(80 min)
SPF
50
7.0 fl oz (mL)

Principal Display Panel - 207 mL Tube Label
AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN  SUNSCREEN BROAD SPECTRUM SPF50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE216 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
OATMEAL (UNII: 8PI54V663Y)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FEVERFEW (UNII: Z64FK7P217)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0304-114 mL in 1 TUBE; Type 0: Not a Combination Product10/01/201602/28/2024
2NDC:69968-0304-388 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2016
3NDC:69968-0304-62 in 1 TRAY11/20/2019
3NDC:69968-0304-388 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:69968-0304-7207 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2016
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 5/2023
Document Id: fab14a17-1ba2-5c47-e053-6294a90afd94
Set id: bbd6710f-a665-437e-b86b-437f732984d1
Version: 7
Effective Time: 20230502
 
Johnson & Johnson Consumer Inc.