Naturium Uv Reflect Antioxidant Spf 50

Naturium Uv Reflect Antioxidant Spf 50
SPL v3
SPL
SPL Set ID 0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c
Route
TOPICAL
Published
Effective Date 2023-11-17
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
Phytate Sodium Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate Butylene Glycol Polyglyceryl-6 Polyricinoleate Polyglyceryl-2 Dipolyhydroxystearate Sodium Benzoate 4-(p-hydroxyphenyl)-2-butanone Squalane Hydroxyethyl Cellulose, Unspecified Citric Acid Monohydrate Poly(methyl Methacrylate; 450000 Mw) Butyloctyl Salicylate Sodium Stearoyl Glutamate Aluminum Starch Octenylsuccinate Caprylyl/capryl Oligoglucoside Propylene Glycol Isododecane Soybean Oil Caprylyl Glycol Sodium Chloride Polyglyceryl-10 Dioleate Triethyl Citrate Phenoxyethanol Lauroyl Lysine Tocopherol Water Disteardimonium Hectorite Octyldodecanol Helianthus Annuus Sprout

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0%

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

For sunscreen use:

  • Shake well before use.
  • Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

  • After 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
  • Children under 6 months: ask a doctor.
  • Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00 a.m. - 2:00 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.

Do Not Use
  • on damaged or broken skin.
Questions?

www.naturium.com

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Product Packaging

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Inactive Ingredients

Aqua/Water/Eau, Isododecane, Polymethyl Methacryate, Butyloctyl Salicylate, Acrylates Copolymer, Saccharomyces Ferment, Aluminum Starch Octenylsuccinate, Butylene Glycol, Polyglyceryl-6 Polyricinoleate, C24-28 Alkyldimethylsiloxy Trimethylsiloxysilicate, Polyglyceryl-2 Dipolyhydroxystearate, Disteardimonium Hectorite, Sodium Chloride, Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Sodium Stearoyl Glutamate, Glycine Soja (Soybean) Oil, Squalane, Raspberry Ketone, Lauroyl Lysine, Caprylyl/Capryl Glucoside, Triethyl Citrate, Polyglyceryl-10 Dioleate, Hydroxyethylcellulose, Octyldodecanol, Tocopherol, Sodium Phytate, Disodium Phosphate, Sodium Phosphate, Sodium Benzoate, Caprylyl Glycol, Propylene Glycol, Citric Acid, Phenoxyethanol.

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

For sunscreen use:

  • Shake well before use.
  • Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

  • After 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
  • Children under 6 months: ask a doctor.
  • Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00 a.m. - 2:00 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.

Do Not Use (Do not use)
  • on damaged or broken skin.
Questions?

www.naturium.com

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Product Packaging

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Inactive Ingredients

Aqua/Water/Eau, Isododecane, Polymethyl Methacryate, Butyloctyl Salicylate, Acrylates Copolymer, Saccharomyces Ferment, Aluminum Starch Octenylsuccinate, Butylene Glycol, Polyglyceryl-6 Polyricinoleate, C24-28 Alkyldimethylsiloxy Trimethylsiloxysilicate, Polyglyceryl-2 Dipolyhydroxystearate, Disteardimonium Hectorite, Sodium Chloride, Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Sodium Stearoyl Glutamate, Glycine Soja (Soybean) Oil, Squalane, Raspberry Ketone, Lauroyl Lysine, Caprylyl/Capryl Glucoside, Triethyl Citrate, Polyglyceryl-10 Dioleate, Hydroxyethylcellulose, Octyldodecanol, Tocopherol, Sodium Phytate, Disodium Phosphate, Sodium Phosphate, Sodium Benzoate, Caprylyl Glycol, Propylene Glycol, Citric Acid, Phenoxyethanol.

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.


Advanced Ingredient Data


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