sun bum spf 30 premium moisturizing sunscreen

sun bum spf 30 premium moisturizing sunscreen
SPL v4
SPL
SPL Set ID 817282c9-a475-4182-b418-21d88db0067a
Route
topical
Published
Effective Date 2017-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (50 mg) octisalate (100 mg) octocrylene
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

Purpose

Sunscreen

Description

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


Medication Information

Warnings

For external use only.

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

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

Description

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

Do Not Use 

on damaged or broken skin.

Package Labeling:

Active Ingredients

Avobenzone 3.00%, Homosalate 5.00%

Octisalate 3.00%, Octocrylene 10.00%

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

Warnings

For external use only.

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

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

Do Not Use  (Do not use )

on damaged or broken skin.

Package Labeling:

Active Ingredients

Avobenzone 3.00%, Homosalate 5.00%

Octisalate 3.00%, Octocrylene 10.00%

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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