aveeno baby ®

aveeno baby ®
SPL v8
SPL
SPL Set ID 17a7492b-5243-48c4-b808-5e9899db7530
Route
topical
Published
Effective Date 2019-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (216 mg)
Inactive Ingredients
octyldodecyl neopentanoate alkyl (c12-15) benzoate paraffin silicon dioxide neopentyl glycol diethylhexanoate ceresin isopropyl myristate adipic acid/diglycol crosspolymer (20000 mpa.s) triethoxycaprylylsilane neopentyl glycol diisostearate caprylyl glycol oat kernel oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-01

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

Directions
  • apply generously and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose, and tops of ears
  • 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
  • package contains small parts, which could cause a choking hazard
Inactive Ingredients

Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Synthetic Wax, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil

Description

Drug Facts

Questions?

Call toll-free 866-428-3366 or 215-273-8755 (collect) .

www.aveeno.com

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 50570-1

Do not use on damaged or broken skin

Active Ingredients

Zinc Oxide (21.6%)

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel 13 G Canister Blister Pack



PEDIATRICIAN RECOMMENDED BRAND



Aveeno



Baby ®



CONTINUOUS



PROTECTION ®



sensitive skin



sunscreen



stick



BROAD SPECTRUM



SPF 50

50

naturally sourced



100% zinc oxide



active ingredient

sweat + water



resistant (80min)

net wt.



0.47 oz (13 g)


Structured Label Content

Warnings

For external use only

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
Purpose

Sunscreen

Directions
  • apply generously and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose, and tops of ears
  • 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 (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • package contains small parts, which could cause a choking hazard
Inactive Ingredients (Inactive ingredients)

Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Synthetic Wax, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil

Questions?

Call toll-free 866-428-3366 or 215-273-8755 (collect) .

www.aveeno.com

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 50570-1 (50570-1)

Do not use on damaged or broken skin

Active Ingredients (Active ingredients)

Zinc Oxide (21.6%)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel 13 G Canister Blister Pack (PRINCIPAL DISPLAY PANEL - 13 g Canister Blister Pack)



PEDIATRICIAN RECOMMENDED BRAND



Aveeno



Baby ®



CONTINUOUS



PROTECTION ®



sensitive skin



sunscreen



stick



BROAD SPECTRUM



SPF 50

50

naturally sourced



100% zinc oxide



active ingredient

sweat + water



resistant (80min)

net wt.



0.47 oz (13 g)


Advanced Ingredient Data


Raw Label Data

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