Sun Bum 50 Premium Moisturizing Sunscreen

Sun Bum 50 Premium Moisturizing Sunscreen
SPL v4
SPL
SPL Set ID 21cb8652-c6d0-0a77-e063-6294a90a6e1e
Route
TOPICAL
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Avobenzone (30 mg) Homosalate (100 mg) Octocrylene
Inactive Ingredients
Edetate Disodium Behenyl Alcohol Bht Methylisothiazolinone .alpha.-tocopherol Acetate Trideceth-6 Glyceryl Stearate Polyaminopropyl Biguanide Ethylhexyl Stearate Ethylhexylglycerin Xanthan Gum Trimethylsiloxysilicate (m/q 0.6-0.8) Butyloctyl Salicylate Caprylyl Methicone Peg-100 Stearate Sodium Polyacrylate (2500000 Mw) Dimethyl Capramide Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Styrene/ammonium Acrylate Copolymer (300000 Mw) Hydrated Silica Dimethicone Vp/hexadecene Copolymer Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Sunscreen

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Sunscreen

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 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Inactive Ingredients

Inactive ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone

Principal Display Panel


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 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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