Sun Bum Spf 70 Premium Moisturizing Sunscreen

Sun Bum Spf 70 Premium Moisturizing Sunscreen
SPL v2
SPL
SPL Set ID ad28aa2d-80b6-38de-e053-2995a90a27a6
Route
TOPICAL
Published
Effective Date 2020-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Water Cetyl Palmitate Hydrated Silica Caprylyl Trisiloxane Glyceryl Monostearate Peg-100 Stearate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Trideceth-6 Dimethicone Ethylhexyl Stearate Phenoxyethanol Dimethyl Capramide Xanthan Gum Butylated Hydroxytoluene Glycyrrhizinate Dipotassium .alpha.-tocopherol Acetate Ethylhexylglycerin Tetrasodium Glutamate Diacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-01

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Warnings

For external use only

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
Do Not Use

on damaged or broken skin

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Inactive Ingredients

water, cetyl palmitate, hydrated silica, acrylates/C12-22 alkyl methacrylate copolymer, 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, tocopheryl acetate, ethylhexyl glycerin, tetrasodium glutamate diacetate

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

Purpose

Sunscreen

Warnings

For external use only

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
Do Not Use (Do not use)

on damaged or broken skin

Questions?

1-877-978-6286

Other Information (Other information)

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, cetyl palmitate, hydrated silica, acrylates/C12-22 alkyl methacrylate copolymer, 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, tocopheryl acetate, ethylhexyl glycerin, tetrasodium glutamate diacetate

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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