Cardinal Health Leader General Protection Sunscreen Spf 30 Clear Continious Spray

Cardinal Health Leader General Protection Sunscreen Spf 30 Clear Continious Spray
SPL v4
SPL
SPL Set ID b6107d22-a992-eaa1-e053-2995a90a29c2
Route
TOPICAL
Published
Effective Date 2020-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Avobenzone (30 mg) Homosalate (100 mg) Octocrylene (20 mg)
Inactive Ingredients
Panthenol Glycerin Medium-chain Triglycerides Butyloctyl Salicylate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Alcohol Stearoxytrimethylsilane .alpha.-tocopherol, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-09

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

Label

Cardinal Health Leader General Protection Sunscreen SPF 30 Clear Continious Spray

5.5 oz (156 g)

NDC 70000-0073-1

Warnings

For external use only

Flammable:

• do not use near heat, flame or while smoking

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

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

Do Not Use

• on damaged or broken skin.

Other Information

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

• may stain or damage some fabrics, materials or surfaces

Active Ingredients

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

Inactive Ingredients

SD alcohol 40-B, butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

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

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

Label

Cardinal Health Leader General Protection Sunscreen SPF 30 Clear Continious Spray

5.5 oz (156 g)

NDC 70000-0073-1

Purpose

Sunscreen

Warnings

For external use only

Flammable:

• do not use near heat, flame or while smoking

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

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

Do Not Use (Do not use)

• on damaged or broken skin.

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

Active Ingredients (Active ingredients)

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

Inactive Ingredients (Inactive ingredients)

SD alcohol 40-B, butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

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

All Sections (JSON)