leader ultra sheer spf 100 sunscreen lotion

leader ultra sheer spf 100 sunscreen lotion
SPL v6
SPL
SPL Set ID b5a467e0-a6ab-4136-8101-f22cc319de58
Route
topical
Published
Effective Date 2019-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (100 mg) oxybenzone (60 mg)
Inactive Ingredients
dimethicone glyceryl stearate/peg-100 stearate silicon dioxide butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer carbomer copolymer type a alpha-tocopherol acetate edetic acid water ethylhexylglycerin caprylyl glycol glycyrrhizinate dipotassium trolamine white wax cyclomethicone 5 phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-12-03

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 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 this product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

water, styrene/acylates copolymer, cyclopentasiloxane, silica, beeswax, glyceryl stearate, PEG-100 stearate, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethylhexylglycerin, tocopheryl, caprylyl glycol, dipotassium glycyrrhizate, disodium EDTA, triethanolamine, phenoxyethanol, fragrance.

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Label

Leader Ultra Sheer SPF 100 Sunscreen Lotion

3 FL OZ (89 mL)

NDC 70000-0535-1

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 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 this product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients (Inactive ingredients)

water, styrene/acylates copolymer, cyclopentasiloxane, silica, beeswax, glyceryl stearate, PEG-100 stearate, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethylhexylglycerin, tocopheryl, caprylyl glycol, dipotassium glycyrrhizate, disodium EDTA, triethanolamine, phenoxyethanol, fragrance.

Label

Leader Ultra Sheer SPF 100 Sunscreen Lotion

3 FL OZ (89 mL)

NDC 70000-0535-1

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 10.0%, Oxybenzone 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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