Aveeno Baby ®

Aveeno Baby ®
SPL v10
SPL
SPL Set ID bbd6710f-a665-437e-b86b-437f732984d1
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (216 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Phenyl Trimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Dimethicone Polyhydroxystearic Acid (2300 Mw) Glycerin Ethyl Methicone (8 Mpa.s) Silicon Dioxide Cetyl Dimethicone 25 Triethoxycaprylylsilane Phenylethyl Alcohol Oatmeal Caprylyl Glycol Glyceryl Dibehenate Sodium Chloride Chlorphenesin Phenoxyethanol Feverfew Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Octyldodecyl Citrate Crosspolymer Cetyl Dimethicone/bis-vinyldimethicone Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-10-01 Until 2025-01-23

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove
Section 50570-1
  • Do not use on damaged or broken skin
Warnings

For external use only

Questions

866-428-3366; Outside US , dial collect 215-273-8755 www.aveeno.com

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
Active Ingredient

Zinc Oxide 21.6%

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

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



3.0 fl oz (88 mL)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Purpose

Sunscreen

Warnings

For external use only

Questions

866-428-3366; Outside US , dial collect 215-273-8755 www.aveeno.com

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
Active Ingredient

Zinc Oxide 21.6%

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

Principal Display Panel 207 Ml Tube Label (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



3.0 fl oz (88 mL)


Advanced Ingredient Data


Raw Label Data

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