Face Reality Daily Spf 30 Plus Sunscreen Spf 30

Face Reality Daily Spf 30 Plus Sunscreen Spf 30
SPL v1
SPL
SPL Set ID 45a3ce12-15fe-4040-95da-ac8513a39fb9
Route
TOPICAL
Published
Effective Date 2024-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Ethylhexyl Salicylate (50 mg) Avobenzone (30 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Glyceryl Monostearate Diethylhexyl 2,6-naphthalate Alkyl (c12-15) Benzoate Dimethicone Glycerin Hamamelis Virginiana Bark Niacinamide Panthenol Bisabolol Cetostearyl Alcohol .alpha.-tocopherol Acetate Sodium Hyaluronate Potassium Azeloyl Diglycinate Allantoin Potassium Cetyl Phosphate Polymethylsilsesquioxane (4.5 Microns) Phenoxyethanol Propylheptyl Caprylate Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Phytate Sodium Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-17

Description

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

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 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Do Not Use
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

Other Information
  • Protect the product from excessive heat and direct sun
Inactive Ingredients:

Aqua (Water), Butyloctyl Salicylate, Glyceryl Stearate, Diethylhexyl 2,6-Naphthalate, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Twig Extract, Niacinamide, Panthenol, Bisabolol, Cetearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Potassium Azeloyl Diglycinate, Allantoin, Potassium Cetyl Phosphate, Polymethylsilsesquioxane, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Phenoxyethanol, Propylheptyl Caprylate, Carbomer, Ethylhexylglycerin, Sodium Phytate, Sodium Hydroxide.

Questions or Comments?

1-866-477-3077

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.
Package Labeling:(70707 451 01)

Package Labeling:(70707 451 02)


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 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

Other Information (Other information)
  • Protect the product from excessive heat and direct sun
Inactive Ingredients: (Inactive ingredients:)

Aqua (Water), Butyloctyl Salicylate, Glyceryl Stearate, Diethylhexyl 2,6-Naphthalate, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Twig Extract, Niacinamide, Panthenol, Bisabolol, Cetearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Potassium Azeloyl Diglycinate, Allantoin, Potassium Cetyl Phosphate, Polymethylsilsesquioxane, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Phenoxyethanol, Propylheptyl Caprylate, Carbomer, Ethylhexylglycerin, Sodium Phytate, Sodium Hydroxide.

Questions or Comments? (Questions or comments?)

1-866-477-3077

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 right away.
Package Labeling:(70707 451 01) (Package Labeling:(70707-451-01))

Package Labeling:(70707 451 02) (Package Labeling:(70707-451-02))


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)