Byoma Moisturizing Gel Sunscreen Broad Spectrum Spf 30

Byoma Moisturizing Gel Sunscreen Broad Spectrum Spf 30
SPL v3
SPL
SPL Set ID f63fe60f-9863-1dfb-e053-2a95a90a90a5
Route
TOPICAL
Published
Effective Date 2023-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg)
Inactive Ingredients
Water Glycerin Butyloctyl Salicylate Propanediol Dimethicone Hyaluronate Sodium Caprylhydroxamic Acid Medium-chain Triglycerides Ceramide Np Cholesterol Phytosphingosine Caprylyl Glycol Dibutyl Ethylhexanoyl Glutamide Stearic Acid Oleic Acid Dibutyl Lauroyl Glutamide Clove Hydroxyacetophenone Lactic Acid Octyldodecanol 1,2-hexanediol Panthenol Pullulan Betasizofiran Tocopherol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-15

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%

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 generously and evenly 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating: • Reapply at least every 2 hours. • Children under 6 months of age: ask a doctor. • 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 sunprotection measures including • Limit time in the sun, especially from 10 a.m.– 2 p.m - Wear long sleeved shirts, pants, hats and sunglasses.









Sun Protection Measures 

Do Not Use

on damaged or broken skin

Drug Facts

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%,

Homosalate 10%,

Octisalate 5%

Inactive Ingredients

Water (Aqua), Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Beta-Glucan, Sodium Hyaluronate, Caprylhydroxamic Acid, Caprylic/Capric Trilgyceride, Ceramide NP, Cholesterol, Phytosphingosine, Caprylyl Glycol, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, Stearic Acid, Oleic Acid, DIbutyl Lauroyl Glutamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Lecithin, Eugenia Caryophyllus (Clove) Bud Extract, Hydroxyacetophenone, Lactic Acid, Lecithin, Octyldodecanol, 1,2-Hexanediol, Panthenol, Poly C10-30 Alkyl Acrylate, Pullulan, Sclerotium Gum, Sodium Polyacryloyldimethyl Taurate, Solidago Virgaurea Extract, Tocopherol, Xanthan Gum.

Questions Or Comments?
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 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

For external use only

Directions

• Apply generously and evenly 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating: • Reapply at least every 2 hours. • Children under 6 months of age: ask a doctor. • 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 sunprotection measures including • Limit time in the sun, especially from 10 a.m.– 2 p.m - Wear long sleeved shirts, pants, hats and sunglasses.









Sun Protection Measures 

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%,

Homosalate 10%,

Octisalate 5%

Inactive Ingredients

Water (Aqua), Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Beta-Glucan, Sodium Hyaluronate, Caprylhydroxamic Acid, Caprylic/Capric Trilgyceride, Ceramide NP, Cholesterol, Phytosphingosine, Caprylyl Glycol, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, Stearic Acid, Oleic Acid, DIbutyl Lauroyl Glutamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Lecithin, Eugenia Caryophyllus (Clove) Bud Extract, Hydroxyacetophenone, Lactic Acid, Lecithin, Octyldodecanol, 1,2-Hexanediol, Panthenol, Poly C10-30 Alkyl Acrylate, Pullulan, Sclerotium Gum, Sodium Polyacryloyldimethyl Taurate, Solidago Virgaurea Extract, Tocopherol, Xanthan Gum.

Questions Or Comments? (Questions or Comments?)
When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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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