heb spf 55 babies and kids sunscreen stick

heb spf 55 babies and kids sunscreen stick
SPL v2
SPL
SPL Set ID f5660a97-57c8-61c7-e053-2995a90a0164
Route
topical
Published
Effective Date 2021-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
white wax .alpha.-tocopherol, dl- butyloctyl salicylate cetyl alcohol myristyl myristate cocoa butter phenoxyethanol tetrahexyldecyl ascorbate ceresin stearyl behenate lauryl lactate polybutene (1400 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-04-01

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%


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 liberally 15 minutes before sun exposure
  • reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months of age: Ask a doctor
  • 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

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Label

do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

inactive Ingredient(s)

beeswax, ozokertie, cetearyl behenate, lauryl lactate, polybutene, butyloctyl salicylate, cetyl alcohol, myristyl myristate, styrene/acrylates copolymer, theobroma cacao (cocoa) seed butter, phenoxyethanol, tetrahexyldecyl ascorbate (vitamin C ester), tocopherol (vitamin E).

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.


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 liberally 15 minutes before sun exposure
  • reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months of age: Ask a doctor
  • 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

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Label

do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

inactive Ingredient(s) (Inactive Ingredient(s))

beeswax, ozokertie, cetearyl behenate, lauryl lactate, polybutene, butyloctyl salicylate, cetyl alcohol, myristyl myristate, styrene/acrylates copolymer, theobroma cacao (cocoa) seed butter, phenoxyethanol, tetrahexyldecyl ascorbate (vitamin C ester), tocopherol (vitamin E).

when Using This Product  (When using this product )

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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