Sun Bum Sunscreen Oil 50 5 Oz

Sun Bum Sunscreen Oil 50 5 Oz
SPL v2
SPL
SPL Set ID 3b2b4ba0-3f89-0a04-e063-6294a90ac1c0
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (100 mg) Homosalate
Inactive Ingredients
Theobroma Cacao (cocoa) Seed Butter Polyamide-8 (4500 Mw) Butyloctyl Salicylate Pongamol Isoamyl Cocoate Tocopherol Cocos Nucifera (coconut) Oil Helianthus Annuus (sunflower) Seed Oil Aloe Barbadensis Leaf Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Simmondsia Chinensis (jojoba) Seed Oil Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Homosalate 10.0 Octocrylene 10.0 Octisalate 5.0 Avobenzone 3.0

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.0 Octocrylene 10.0 Octisalate 5.0 Avobenzone 3.0

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

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.

Directions

• shake well before use

• hold container 4 to 6 inches from the skin to apply

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

• do not spray directly onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• 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

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 10.0

Octocrylene 10.0

Octisalate 5.0

Avobenzone 3.0

Inactive Ingredients

cocos nucifera (coconut) oil, isoamyl cocoate, alcohol denat. (6%), butyloctyl salicylate, capryloyl glycerin/sebacic acid copolymer, polyester-8, polyamide-8, simmondsia chinensis (jojoba) seed oil, tocopherol, helianthus annuus (sunflower) seed oil, pongamol, aloe barbadensis leaf extract, theobroma cacao (cocoa) seed butter


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

Purpose

Sunscreen

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.

Directions

• shake well before use

• hold container 4 to 6 inches from the skin to apply

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

• do not spray directly onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• 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

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 10.0

Octocrylene 10.0

Octisalate 5.0

Avobenzone 3.0

Inactive Ingredients (Inactive ingredients)

cocos nucifera (coconut) oil, isoamyl cocoate, alcohol denat. (6%), butyloctyl salicylate, capryloyl glycerin/sebacic acid copolymer, polyester-8, polyamide-8, simmondsia chinensis (jojoba) seed oil, tocopherol, helianthus annuus (sunflower) seed oil, pongamol, aloe barbadensis leaf extract, theobroma cacao (cocoa) seed butter


Advanced Ingredient Data


Raw Label Data

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