cardinal health leader general protection sunscreen spf 50 lotion

cardinal health leader general protection sunscreen spf 50 lotion
SPL v4
SPL
SPL Set ID b623defb-4a9d-6fc5-e053-2995a90ae846
Route
topical
Published
Effective Date 2020-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) octocrylene (70 mg) homosalate (150 mg) octisalate (50 mg)
Inactive Ingredients
water carbomer interpolymer type a (allyl sucrose crosslinked) sorbitol trolamine polyethyloxazoline (5000 mw) dimethicone tridecyl salicylate phenoxyethanol ethylhexylglycerin edetate disodium stearic acid .alpha.-tocopherol, dl- benzyl alcohol aluminum starch octenylsuccinate polyglyceryl-3 distearate caprylyl glycol sorbitan isostearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-10

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%


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 and evenly 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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

Label

Cardinal Health Leader General Protection Sunscreen SPF 50 Lotion

8 fl oz (237 mL)

NDC 70000-0075-1

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

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 and evenly 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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance

Label

Cardinal Health Leader General Protection Sunscreen SPF 50 Lotion

8 fl oz (237 mL)

NDC 70000-0075-1

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

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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