Sun Bum 70 Premium Sunscreen

Sun Bum 70 Premium Sunscreen
SPL v2
SPL
SPL Set ID 3b02811d-dc66-fc6f-e063-6294a90aefc8
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Avobenzone (30 mg) Octisalate (50 mg) Homosalate (150 mg)
Inactive Ingredients
Dimethicone Peg-100 Stearate Trimethylsiloxysilicate (m/q 0.6-0.8) Cetyl Dimethicone 25 Ethylhexyl Stearate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Bht .alpha.-tocopherol Acetate Dipotassium Glycyrrhizate Tetrasodium Glutamate Diacetate Water Hydrated Silica Phenoxyethanol Glyceryl Stearate Dimethyl Capramide Sodium Polyacrylate (8000 Mw) Xanthan Gum Ethylhexylglycerin Cetyl Palmitate Caprylyl Methicone Luviset 360 Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Trideceth-6

Identifiers & Packaging

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

Description

AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%

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 15%, OCTISALATE 5%, OCTOCRYLENE 10%

Inactive Ingredients

WATER, CETYL PALMITATE, HYDRATED SILICA, ACRYLATES/C12-22 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL METHICONE, STYRENE/ACRYLATES COPOLYMER, CETYL DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, POLYESTER-8, TRIDECETH-6, DIMETHICONE, ETHYLHEXYL STEARATE, FRAGRANCE, PHENOXYETHANOL, DIMETHYL CAPRAMIDE, SODIUM POLYACRYLATE, TRIMETHYLSILOXYSILICATE, XANTHAN GUM, BHT, DIPOTASSIUM GLYCYRRHIZATE, TOCOPHEROL ACETATE, ETHYLHEXYLGLYCERIN, TETRASODIUM GLUTAMATE DIACETATE


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

AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%

Inactive Ingredients

WATER, CETYL PALMITATE, HYDRATED SILICA, ACRYLATES/C12-22 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL METHICONE, STYRENE/ACRYLATES COPOLYMER, CETYL DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, POLYESTER-8, TRIDECETH-6, DIMETHICONE, ETHYLHEXYL STEARATE, FRAGRANCE, PHENOXYETHANOL, DIMETHYL CAPRAMIDE, SODIUM POLYACRYLATE, TRIMETHYLSILOXYSILICATE, XANTHAN GUM, BHT, DIPOTASSIUM GLYCYRRHIZATE, TOCOPHEROL ACETATE, ETHYLHEXYLGLYCERIN, TETRASODIUM GLUTAMATE DIACETATE


Advanced Ingredient Data


Raw Label Data

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