Protekt Spf-50 Sheer Mineral Sunscreen

Protekt Spf-50 Sheer Mineral Sunscreen
SPL v4
SPL
SPL Set ID 6edc0941-bb21-4797-a875-81f727694774
Route
TOPICAL
Published
Effective Date 2022-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (180 mg)
Inactive Ingredients
Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Safflower Citric Acid Monohydrate Decyl Glucoside Dodecane Glycerin Glyceryl Laurate Glyceryl Stearate Citrate Helianthus Annuus Flowering Top Hydrogenated Methyl Abietate Punica Granatum Root Bark Stearic Acid Tetrasodium Glutamate Diacetate Cocoa Tocopherol Tridecyl Salicylate Xanthan Gum Corn Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Zinc Oxide 18.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18.00%

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

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

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Zinc Oxide 18.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, *Carthamus Tinctorius (Safflower) Oil, Citric Acid, Decyl Glucoside, Dodecane, *Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. (*Certified Organic Ingredient)

When Using This Product
  • keep out of eyes. Rinse with water to remove 
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use

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

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Zinc Oxide 18.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, *Carthamus Tinctorius (Safflower) Oil, Citric Acid, Decyl Glucoside, Dodecane, *Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. (*Certified Organic Ingredient)

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 develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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

All Sections (JSON)