Sabiya Broad Spectrum Spf-50

Sabiya Broad Spectrum Spf-50
SPL v1
SPL
SPL Set ID 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c
Route
TOPICAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (180 mg)
Inactive Ingredients
Aloe Vera Leaf Water Shea Butter Medium-chain Triglycerides Caprylyl Glycol Citric Acid Monohydrate Coconut Oil Decyl Glucoside Dodecane Glycerin Glyceryl Laurate Glyceryl Monostearate Isododecane Pearl (hyriopsis Cumingii) Sodium Stearoyl Glutamate Sorbitan Monostearate Starch, Tapioca Edetate Sodium .alpha.-tocopherol Tridecyl Salicylate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-20

Description

Zinc Oxide 18%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18%

Uses
  • Helps prevent sunburn
  • higher SPF gives more sunburn protection 
  • retains SPF after 80 minutes of swimming or sweating.
  • 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
  • Shake well prior to use 
  • Apply liberally and evenly to dry skin 15 minutes before sun exposure 
  • reapply after 80 minutes of swimming or sweating 
  • immediately after towel drying
  • at least every 2 hours. 
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses 
  • use a water-resistant sunscreen if swimming or sweating 
  • children under 6 months of age: Ask a doctor
Do Not Use
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Zinc Oxide 18%

Other Information
  • Protect this product and its container from excessive heat and direct sun. 
Package Labeling:

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice • Aqua (Deionized Water) • Butyrospermum Parkii (Shea) Butter • Caprylic/Capric Triglyceride • Caprylyl Glycol • Citric Acid • Coos Nucifera (Coconut) Oil • Decyl Glucoside • Dodecane • Fucus Vesiculosus (Seaweed) Extract • Glycerin• Glyceryl Laurate • Glyceryl Stearate • Glyceryl Undecylenate • Isododecane • Macrocystis Pyrifera (Sea Kelp) Extract • Parfum (Fragrance) • Pearl Powder • Polyhydroxystearic Acid •Saccharomyces Ferment Filtrate • Sargassum Vulgare (Algae) Extract • Sodium Stearoyl Glutamate • Sorbitan Stearate •Tapioca Starch • Tetrasodium EDTA • Tocopherol (Vitamin E) • Tridecyl Salicylate • Trimethylsiloxysilicate • Xanthan Gum • 

Questions Or Comments?

Visit www.sabiya.comor call + 1 (754) 216-3334

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation 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
  • higher SPF gives more sunburn protection 
  • retains SPF after 80 minutes of swimming or sweating.
  • 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
  • Shake well prior to use 
  • Apply liberally and evenly to dry skin 15 minutes before sun exposure 
  • reapply after 80 minutes of swimming or sweating 
  • immediately after towel drying
  • at least every 2 hours. 
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses 
  • use a water-resistant sunscreen if swimming or sweating 
  • children under 6 months of age: Ask a doctor
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Zinc Oxide 18%

Other Information
  • Protect this product and its container from excessive heat and direct sun. 
Package Labeling:

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice • Aqua (Deionized Water) • Butyrospermum Parkii (Shea) Butter • Caprylic/Capric Triglyceride • Caprylyl Glycol • Citric Acid • Coos Nucifera (Coconut) Oil • Decyl Glucoside • Dodecane • Fucus Vesiculosus (Seaweed) Extract • Glycerin• Glyceryl Laurate • Glyceryl Stearate • Glyceryl Undecylenate • Isododecane • Macrocystis Pyrifera (Sea Kelp) Extract • Parfum (Fragrance) • Pearl Powder • Polyhydroxystearic Acid •Saccharomyces Ferment Filtrate • Sargassum Vulgare (Algae) Extract • Sodium Stearoyl Glutamate • Sorbitan Stearate •Tapioca Starch • Tetrasodium EDTA • Tocopherol (Vitamin E) • Tridecyl Salicylate • Trimethylsiloxysilicate • Xanthan Gum • 

Questions Or Comments? (Questions or Comments?)

Visit www.sabiya.comor call + 1 (754) 216-3334

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 or irritation 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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