AVEENO BABY NATURAL PROTECTION SUNSCREEN  BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide 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® natural protection lotion sunscreen BROAD SPECTRUM SPF 50

Drug Facts

Active Ingredient

Titanium Dioxide (6%), Zinc Oxide (3%)

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
  • apply to all skin exposed to the sun
  • 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, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, PEG-8, Beeswax, Dimethylimidazolidinone Rice Starch, Polyamide-5, Butylene Glycol, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate, PEG-100 Stearate, Benzyl Alcohol, Polyhydroxystearic Acid, Arachidyl Alcohol, Caprylyl Glycol, Dipropylene Glycol Dibenzoate, Glycerin, Pentylene Glycol, Behenyl Alcohol, Triethoxycaprylylsilane, Xanthan Gum, Trisiloxane, Bisabolol, Citric Acid, Acrylates/Dimethicone Copolymer, Arachidyl Glucoside, PPG-15 Stearyl Ether Benzoate, Chlorphenesin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Dipotassium Glycyrrhizate, Polyaminopropyl Biguanide, Sodium Citrate, Hydroxyphenyl Propamidobenzoic Acid, Polysorbate 60, Avena Sativa (Oat) Kernel Extract

Questions?

Call toll-free 866-4AVEENO or 215-273-8755 (collect) 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 - 85 g Tube Label

Aveeno®
Baby®

natural
protection
100% naturally sourced
sunscreen ingredients
lotion

sunscreen

BROAD
SPECTRUM
SPF 50

for sensitive skin
with soothing oat
fragrance free

sweat + water
resistant (80 min)

PEDIATRICIAN
RECOMMENDED

NET WT. 3 OZ. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
AVEENO BABY NATURAL PROTECTION SUNSCREEN   BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide60 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Dimethicone (UNII: 92RU3N3Y1O)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Dipropylene Glycol Dibenzoate (UNII: 6OA5ZDY41O)  
Glycerin (UNII: PDC6A3C0OX)  
Pentylene Glycol (UNII: 50C1307PZG)  
Docosanol (UNII: 9G1OE216XY)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Xanthan Gum (UNII: TTV12P4NEE)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Levomenol (UNII: 24WE03BX2T)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
PPG-15 Stearyl Ether Benzoate (UNII: 80D2J6361M)  
Chlorphenesin (UNII: I670DAL4SZ)  
Squalane (UNII: GW89575KF9)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
POLIHEXANIDE (UNII: 322U039GMF)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Oat (UNII: Z6J799EAJK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-0805-385 g in 1 TUBE; Type 0: Not a Combination Product09/13/201207/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/13/201207/30/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 7/2018
 
Johnson & Johnson Consumer Inc.