cardinal health leader sport sunscreen spf 30 clear continuous spray

cardinal health leader sport sunscreen spf 30 clear continuous spray
SPL v5
SPL
SPL Set ID b62329d7-29e9-d111-e053-2a95a90aab06
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) homosalate (100 mg) octisalate (50 mg) octocrylene (20 mg)
Inactive Ingredients
acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) alcohol glycerin stearoxytrimethylsilane butyloctyl salicylate .alpha.-tocopherol, dl- panthenol medium-chain triglycerides

Identifiers & Packaging

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

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%


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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area

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

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

Label

Flammable

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

When Using This Product

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

• Keep away from face to avoid breathing it. • do not puncture or incinerate.

Contents under pressure. • do not store at temperatures above 120° F.

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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area

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)

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Label

Flammable

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

When Using This Product (When using this product)

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

• Keep away from face to avoid breathing it. • do not puncture or incinerate.

Contents under pressure. • do not store at temperatures above 120° F.

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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