Sun Bum Daily Body

Sun Bum Daily Body
SPL v5
SPL
SPL Set ID 15da0cb1-e695-cec3-e063-6394a90a1afa
Route
TOPICAL
Published
Effective Date 2024-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Avobenzone (30 mg) Octocrylene (90 mg) Homosalate (80 mg)
Inactive Ingredients
Propanediol Phenoxyethanol Isododecane Polyglyceryl-6 Behenate Glycerin Polymethylsilsesquioxane (11 Microns) Fragrance 13576 Butyloctyl Salicylate Aminomethyl Propanol Lysophosphatidylcholine, Soybean Tocopherol Tetrahexyldecyl Ascorbate Sodium Polyacrylate (2500000 Mw) Ethylhexylglycerin Trisodium Ethylenediamine Disuccinate Pullulan Polyglyceryl-6 Stearate Water Butyl Acrylate/methyl Methacrylate/trimethylsiloxymethacrylate Copolymer Pongamia Pinnata Seed Xanthan Gum Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Sclerotium Gum Silica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-26

Description

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 9%

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

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 9%

Inactive Ingredients

water, butyloctyl salicylate, polymethyl-silsesquioxane, fragrance, acrylates/C10-30 alkyl acrylate cross-polymer, acrylates/polytrimethylsiloxymethacrylate copolymer, aminomethyl propanol, ethylhexylglycerin, glycerin, isododecane, lysolecithin, phenoxyethanol, polyglyceryl-6 behenate, polyglyceryl-6 stearate, pongamia pinnata seed extract, propanediol, pullulan, sclerotium gum, silica, sodium polyacrylate, tetrahexyldecyl ascorbate, tocopherol, trisodium ethylenediamine disuccinate, xanthan gum


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 (Other information)

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 9%

Inactive Ingredients (Inactive ingredients)

water, butyloctyl salicylate, polymethyl-silsesquioxane, fragrance, acrylates/C10-30 alkyl acrylate cross-polymer, acrylates/polytrimethylsiloxymethacrylate copolymer, aminomethyl propanol, ethylhexylglycerin, glycerin, isododecane, lysolecithin, phenoxyethanol, polyglyceryl-6 behenate, polyglyceryl-6 stearate, pongamia pinnata seed extract, propanediol, pullulan, sclerotium gum, silica, sodium polyacrylate, tetrahexyldecyl ascorbate, tocopherol, trisodium ethylenediamine disuccinate, xanthan gum


Advanced Ingredient Data


Raw Label Data

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