yse beauty skin glow spf 30 primer

yse beauty skin glow spf 30 primer
SPL v2
SPL
SPL Set ID 2b043874-b21f-43f3-8e67-486933ecc02e
Route
topical
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (60 mg) octisalate (50 mg) octocrylene (75 mg)
Inactive Ingredients
water propanediol butyloctyl salicylate cetostearyl alcohol polymethylsilsesquioxane (4.5 microns) dimethicone dicaprylyl carbonate bismuth oxychloride glyceryl monostearate sodium stearoyl glutamate phenoxyethanol mica ethylhexyl hydroxystearate xanthan gum ferric oxide red ferric oxide yellow ferrosoferric oxide helianthus annuus seed wax rice bran chlorphenesin caprylyl glycol niacinamide titanium dioxide stearyl glycyrrhetinate tetrasodium glutamate diacetate helianthus annuus flowering top sucrose glycyrrhiza glabra sodium hydroxide polyglycerin-3 tocopherol rosemary arthrospira maxima hyaluronate sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-28

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 6% Octisalate 5% Octocrylene 7.5%


Medication Information

Warnings

For external use only.

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

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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
  • Children under 6 months: Ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

Water (Aqua), Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Polymethylsilsesquioxane, Dimethicone, Dicaprylyl Carbonate, Bismuth Oxychloride (CI 77163), Glyceryl Stearate, Jojoba Esters, Sodium stearoyl Glutamate, Phenoxyethanol, Dimethicone Crosspolymer, Mica, Ethylhexyl Hydroxystearate, Xanthan Gum, Iron Oxides (CI 77491, CI 77492, CI 77499), ZHelianthus Annus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Niacinamide, Titanium Dioxide (CI 77891), Ethylhexylglycerin Hexylene Glycol, Niacinamide, Titanium Dioxide (CI 77891), Ethylhexylglycerin Hexylene Glycol, Stearyl Glycyrrhetinate, Tetrasodium Glutamate Diacetate, Helianthus Annuus (Sunflower) Extract, Sucrose, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hydroxide, Polyglycerin-3, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Spirulina Maxima Extract, Sodium Hyaluronate, Lecithin.

Description

Avobenzone 3% Homosalate 6% Octisalate 5% Octocrylene 7.5%

Drug Facts

Do Not Use 
  • on damaged or broken skin
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Octocrylene 7.5%

Questions Or Comments

Call 1-866-717-1436

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.
  • Keep outer carton for complete labeling information

Structured Label Content

Warnings

For external use only.

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

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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
  • Children under 6 months: Ask a doctor
Other Information (Other information)
  • Protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Polymethylsilsesquioxane, Dimethicone, Dicaprylyl Carbonate, Bismuth Oxychloride (CI 77163), Glyceryl Stearate, Jojoba Esters, Sodium stearoyl Glutamate, Phenoxyethanol, Dimethicone Crosspolymer, Mica, Ethylhexyl Hydroxystearate, Xanthan Gum, Iron Oxides (CI 77491, CI 77492, CI 77499), ZHelianthus Annus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Niacinamide, Titanium Dioxide (CI 77891), Ethylhexylglycerin Hexylene Glycol, Niacinamide, Titanium Dioxide (CI 77891), Ethylhexylglycerin Hexylene Glycol, Stearyl Glycyrrhetinate, Tetrasodium Glutamate Diacetate, Helianthus Annuus (Sunflower) Extract, Sucrose, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hydroxide, Polyglycerin-3, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Spirulina Maxima Extract, Sodium Hyaluronate, Lecithin.

Drug Facts

Do Not Use  (Do not use )
  • on damaged or broken skin
Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 6%

Octisalate 5%

Octocrylene 7.5%

Questions Or Comments (Questions or comments)

Call 1-866-717-1436

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.
  • Keep outer carton for complete labeling information

Advanced Ingredient Data


Raw Label Data

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