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

Purpose

Sunscreen

Description

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%


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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Other Information
  • Protect the product from excessive heat and direct sun
Description

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

Do Not Use
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

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

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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Other Information (Other information)
  • Protect the product from excessive heat and direct sun
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Homosalate 10.0%, Octisalate 5.0%, Avobenzone 3.0%

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

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