Beet The Sun Lightweight Sunscreen Broad Spectrum Spf 40 Pa+++

Beet The Sun Lightweight Sunscreen Broad Spectrum Spf 40 Pa+++
SPL v3
SPL
SPL Set ID f5c795f0-63bc-3033-e053-2995a90a55ab
Route
TOPICAL
Published
Effective Date 2023-02-25
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 Propanediol Pentylene Glycol Sodium Acrylate Levomenol Ethylhexyl Methoxycrylene Hydroxyacetophenone Beet Isohexadecane Polysorbate 80 Hyaluronic Acid .alpha.-tocopherol Acetate Caprylyl Glycol Salix Alba Bark Trisodium Ethylenediamine Disuccinate 1,2-hexanediol Xanthan Gum Citric Acid Monohydrate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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
  • Avoid contact with eyes. 
  • For external use only.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating 
  • Reapply at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:  Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m.-2 p.m. / Wear long sleeved shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor
Do Not Use
  • on damaged or broken skin. Rinse with water to remove.
Other Information
  • Protect the product in this container from excessive heat and direct sunlight.   
  • You may report a serious adverse event from use of this product to: [email protected]
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 3%

Inactive Ingredients

Water (Aqua), Propanediol, Pentylene Glycol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Bisabolol, Ethylhexyl Methoxycrylene, Hydroxyacetophenone, Beta Vulgaris (Beet) Root Extract, Isohexadecane, Polysorbate 80, Hyaluronic Acid, Tocopheryl Acetate, Caprylyl Glycol, Eugenia Caryophyllus Bud Extract, Solidago Virgaurea Extract, Salix Alba (Willow) Bark Extract, Trisodium Ethylenediamine Disuccinate, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Citric Acid, Sodium Hydroxide

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 right away.


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
  • Avoid contact with eyes. 
  • For external use only.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating 
  • Reapply at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:  Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m.-2 p.m. / 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. Rinse with water to remove.
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sunlight.   
  • You may report a serious adverse event from use of this product to: [email protected]
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 3%

Inactive Ingredients

Water (Aqua), Propanediol, Pentylene Glycol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Bisabolol, Ethylhexyl Methoxycrylene, Hydroxyacetophenone, Beta Vulgaris (Beet) Root Extract, Isohexadecane, Polysorbate 80, Hyaluronic Acid, Tocopheryl Acetate, Caprylyl Glycol, Eugenia Caryophyllus Bud Extract, Solidago Virgaurea Extract, Salix Alba (Willow) Bark Extract, Trisodium Ethylenediamine Disuccinate, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Citric Acid, Sodium Hydroxide

Stop Use and Ask A Doctor If (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 right away.


Advanced Ingredient Data


Raw Label Data

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