Sun Bum Spf 15 Premium Moisturizing Sunscreen

Sun Bum Spf 15 Premium Moisturizing Sunscreen
SPL v1
SPL
SPL Set ID d912d9ba-0203-05f6-e053-2995a90a58d1
Route
TOPICAL
Published
Effective Date 2022-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Homosalate (50 mg) Octisalate (100 mg) Octocrylene
Inactive Ingredients
Water Butyloctyl Salicylate Hydrated Silica Styrene Dimethicone Vinylpyrrolidone/hexadecene Copolymer Caprylyl Trisiloxane Ethylhexyl Stearate Trideceth-6 Glyceryl Monostearate Polyethylene Glycol 4500 Docosanol Dimethyl Capramide Ethylhexylglycerin Xanthan Gum Polyaminopropyl Biguanide .alpha.-tocopherol Acetate Butylated Hydroxytoluene Edetate Disodium Anhydrous Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-02-16

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Uses

• Helps prevent sunburn • higher SPF gives more sunburn protection • Ifusedasdirectedwithothersunprotectionmeasures(seeDirections), decreasestheriskofskincancerandearlyskinagingcausedbythesun

Warnings

For external use only

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply: After 80 minutes of swimming or sweating.

• Immediately after towel drying • At least every 2 hours.

• 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 Broad Spectrum SPF of 15 or higher and other sun protection measures, including:

• Limit time in the sun, especially from 10 am - 2 pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

Do Not Use
  • on damaged or broken skin
Questions?

1-877-978-6286

Otherinformation

protectthis product from excessive heat and direct sun

Package Labeling:

Active Ingredients

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

Inactive Ingredients

water, butyloctylsalicylate, hydratedsilica, styrene/acrylatescopolymer, dimethicone, VP/hexadecene copolymer, 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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

• Helps prevent sunburn • higher SPF gives more sunburn protection • Ifusedasdirectedwithothersunprotectionmeasures(seeDirections), decreasestheriskofskincancerandearlyskinagingcausedbythesun

Purpose

Sunscreen

Warnings

For external use only

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply: After 80 minutes of swimming or sweating.

• Immediately after towel drying • At least every 2 hours.

• 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 Broad Spectrum SPF of 15 or higher and other sun protection measures, including:

• Limit time in the sun, especially from 10 am - 2 pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

Do Not Use (Do not use)
  • on damaged or broken skin
Questions?

1-877-978-6286

Otherinformation

protectthis product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

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

Inactive Ingredients

water, butyloctylsalicylate, hydratedsilica, styrene/acrylatescopolymer, dimethicone, VP/hexadecene copolymer, 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

When Using This Product: (When using this product:)
  • Keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if rash occurs
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

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