Sun Bum Spf 50 Premium Moisturizing Sunscreen

Sun Bum Spf 50 Premium Moisturizing Sunscreen
SPL v4
SPL
SPL Set ID 5fbd57cc-e167-47ba-a592-3e592abb2070
Route
TOPICAL
Published
Effective Date 2017-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Avobenzone (30 mg) Homosalate (50 mg) Octisalate
Inactive Ingredients
Water Butyloctyl Salicylate Hydrated Silica Vinylpyrrolidone/hexadecene Copolymer Dimethicone Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Caprylyl Trisiloxane Ethylhexyl Stearate Trideceth-6 Glyceryl Monostearate Peg-100 Stearate Docosanol Dimethyl Capramide Ethylhexylglycerin Xanthan Gum .alpha.-tocopherol Acetate Butylated Hydroxytoluene Edetate Disodium Anhydrous Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-26

Description

Avobenzone 3.00%, Homosalate 10.00% Octisalate 5.00%, Octocrylene 10.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00%, Homosalate 10.00% Octisalate 5.00%, Octocrylene 10.00%

Uses
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection.
  • 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.

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 a 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-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.
Do Not Use 

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%

Octisalate 5.00%, Octocrylene 10.00%

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.

Questions Or Comments?

Call +1 (877) 978-6286

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.
  • 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.

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 a 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-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.
Do Not Use  (Do not use )

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%

Octisalate 5.00%, Octocrylene 10.00%

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.

Questions Or Comments? (Questions or Comments?)

Call +1 (877) 978-6286

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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