Sun Bum 15 Premium Sunscreen Browning

Sun Bum 15 Premium Sunscreen Browning
SPL v1
SPL
SPL Set ID 3c5b0db8-f05a-2b5c-e063-6294a90ae79b
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (50 mg) Avobenzone (20 mg) Octisalate (100 mg) Octocrylene
Inactive Ingredients
Caprylic/capric Triglyceride Argan Oil Kukui Nut Oil Coffea Arabica (coffee) Seed Oil Tocopherol Phenoxyethanol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Manganese Sulfate Isohexadecane Polysorbate 60 Cetyl Alcohol Blue 1 Food Yellow 3 Free Acid Macadamia Ternifolia Seed Oil Red 4 Glyceryl Stearate Helianthus Annuus Flowering Top Caramel Ethylhexylglycerin .alpha.-tocopherol Acetate Magnesium Sulfate Sodium Hydroxide Peg-100 Stearate Carica Papaya (papaya) Fruit Glycerin Laminaria Digitata Hydrolyzed Alginic Acid Red 33 Water Cocos Nucifera (coconut) Oil Aloe Barbadensis Leaf Juice Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Caffeine Ginger

Identifiers & Packaging

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

Description

Homosalate: 5% Octocrylene: 10% Octisalate: 2% Avobenzone 2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate: 5% Octocrylene: 10% Octisalate: 2% Avobenzone 2%

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

• 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

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate: 5%

Octocrylene: 10%

Octisalate: 2%

Avobenzone 2%

Inactive Ingredients

water, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, carica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no. 1, red no. 33, red no. 4, yellow no. 6


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

• 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

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate: 5%

Octocrylene: 10%

Octisalate: 2%

Avobenzone 2%

Inactive Ingredients

water, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, carica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no. 1, red no. 33, red no. 4, yellow no. 6


Advanced Ingredient Data


Raw Label Data

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