leader general protection spf 30 sunscreen lotion

leader general protection spf 30 sunscreen lotion
SPL v7
SPL
SPL Set ID 9544b046-055e-5886-e053-2a95a90ad09e
Route
topical
Published
Effective Date 2021-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene
Inactive Ingredients
water sorbitol trolamine ethylhexyl palmitate polyamide-8 (4500 mw) diethylhexyl syringylidenemalonate benzyl alcohol medium-chain triglycerides carbomer copolymer type a chlorphenesin sodium ascorbyl phosphate tocopherol vitamin a palmitate oleth-3 edetic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-19

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% 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

S un 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, sorbitol, ethylhexyl palmitate, polyamide-8, benzyl alcohol, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, retinyl palmitate, oleth-3, disodium EDTA

Description

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

Section 51945-4

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

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

S un 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, sorbitol, ethylhexyl palmitate, polyamide-8, benzyl alcohol, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, retinyl palmitate, oleth-3, disodium EDTA

Section 51945-4 (51945-4)

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 10.0%

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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