Sun Bum Face 50 Sunscreen Lotion

Sun Bum Face 50 Sunscreen Lotion
SPL v4
SPL
SPL Set ID 4032e623-f958-4e7a-afa3-afc844c6b4e0
Route
TOPICAL
Published
Effective Date 2017-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-05

Description

Avobenzone 3 %, Homosalate 10% Octisalate 5.%, Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3 %, Homosalate 10% 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.

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.
  • 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 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-sleeve shirts, pants, hats, and sunglasses.
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 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10%

Inactive Ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, 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 swallowed, get medical help or contact a Poison Control Center immediately.


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.

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.
  • 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 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-sleeve shirts, pants, hats, and sunglasses.
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 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10%

Inactive Ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, 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 swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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