Sun Bum Face And Body Stick 40

Sun Bum Face And Body Stick 40
SPL v5
SPL
SPL Set ID 20d9d60d-e0ce-a177-e063-6394a90a162e
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (35 mg) Avobenzone (25 mg) Octocrylene (50 mg) Octisalate
Inactive Ingredients
Stearic Acid C18-38 Alkyl Hydroxystearoyl Stearate Water Butyloctyl Salicylate Vinylpyrrolidone/hexadecene Copolymer .alpha.-tocopherol Acetate Fd&c Yellow No. 5 Candelilla Wax Propanediol Pongamia Pinnata Seed Glycerin Carthamus Tinctorius Seed Oleosomes Ethylhexylglycerin Sorbitan Olivate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-29

Description

Active ingredients: Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.5%, Octocrylene 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Active ingredients: Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.5%, Octocrylene 5%

Uses

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

Warnings

Warnings

For external use only

Do not use on damaged or broken skin

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 immediately.

Questions

Questions? 1-877-978-6286

Directions

Directions

• shake well before use

• 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

Primary Artwork

Other Information

Other information

protect this product from excessive heat and direct sun

Active Ingredients

Active ingredients:

Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.5%, Octocrylene 5%

Inactive Ingredients

Inactive ingredients

water, carthamus tinctorius (safflower) oleosomes, sodium stearate, butyloctyl salicylate, euphorbia cerifera (candelilla) wax, propanediol, sorbitan olivate, VP/hexadecene copolymer, glycerin, fragrance, phenoxyethanol, C18-38 alkyl hydroxystearoyl stearate, pongamia pinnata seed extract, tocopheryl acetate, ethylhexylglycerin, yellow 5 lake


Structured Label Content

Uses

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

Warnings

Warnings

For external use only

Do not use on damaged or broken skin

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 immediately.

Questions

Questions? 1-877-978-6286

Directions

Directions

• shake well before use

• 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

Primary Artwork

Other Information (Other information)

Other information

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Active ingredients:

Avobenzone 2.5%, Homosalate 3.5%, Octisalate 2.5%, Octocrylene 5%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

water, carthamus tinctorius (safflower) oleosomes, sodium stearate, butyloctyl salicylate, euphorbia cerifera (candelilla) wax, propanediol, sorbitan olivate, VP/hexadecene copolymer, glycerin, fragrance, phenoxyethanol, C18-38 alkyl hydroxystearoyl stearate, pongamia pinnata seed extract, tocopheryl acetate, ethylhexylglycerin, yellow 5 lake


Advanced Ingredient Data


Raw Label Data

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