equate sunscreen baby broad spectrum spf 50 lotion

equate sunscreen baby broad spectrum spf 50 lotion
SPL v4
SPL
SPL Set ID b2083cbd-ef19-4edc-9d7d-eca3452ee0ee
Route
topical
Published
Effective Date 2022-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octocrylene (60 mg)
Inactive Ingredients
aloe vera leaf water stearyl alcohol glycerin butyl acrylate/c16-c20 alkyl methacrylate/methacrylic acid/methyl methacrylate copolymer cetyl alcohol carbomer homopolymer type c (allyl pentaerythritol crosslinked) ceteth-10 phosphate dihexadecyl phosphate coco glucoside xanthan gum edetate disodium methyl dihydroabietate lauryl peg-8 dimethicone (300 cps) cetostearyl alcohol sodium ascorbyl phosphate .alpha.-tocopherol acetate phenoxyethanol trolamine propylene glycol hydroxyacetophenone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-01-10

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octocrylene 6.0%


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

Inactive Ingredients

water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone

Description

Avobenzone 3.0% Homosalate 10.0% Octocrylene 6.0%

Label

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%

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 (Other information)

• protect the product in this container from excessive heat and direct sun



• may stain or damage some fabrics/materials or surfaces

Inactive Ingredients (Inactive ingredients)

water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone

Label

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%

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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