Guidance To Glow Tru Spf-35

Guidance To Glow Tru Spf-35
SPL v1
SPL
SPL Set ID 21b4747b-b173-43c9-b0d4-1dbba5775ff8
Route
TOPICAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (120 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Water Butyloctyl Salicylate Shea Butter Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Cetostearyl Alcohol Citric Acid Monohydrate Coconut Oil Carrot Dodecane Glycerin Glyceryl Laurate Helianthus Annuus Flowering Top Isododecane C13-14 Isoparaffin Laureth-7 Magnesium Aluminum Silicate Apple Polysorbate 20 Potassium Sorbate Hyaluronate Sodium Sodium Stearoyl Glutamate Squalane Tetrasodium Glutamate Diacetate .alpha.-tocopherol Acetate Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-12

Description

Zinc Oxide 12%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 12%

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 ok skin cancer and early skin aging caused by the sun

Warnings:

For external use ONLY

Do Not Use

on damaged 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
  • Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. Regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including

  • Limit time in the sun especially from 10a.m - 2 p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses
Any Questions?

818-863-6299

Other Information

Protect the product in this container from excessive heat and direct sun.

Water Resistant 80 minutes.

Package Labeling:

Active Ingredients

Zinc Oxide 12%

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capris Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Malus Domestica (Apple) Extract Phenoxyethanol, Plankton Extract, Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Potassium Sorbate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Squalane, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol

When Using This Product:

keep out of eyes Rinse with water to remove

Stop Use and Ask A Doctor:

Rash or irritation develops and lasts

If Pregnant Or Breastfeeding,

ask a health professional before use

Keep Out of Reach of Children.

If swallowed,get medical help or contact a poison control center right way.


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 ok 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 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
  • Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. Regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including

  • Limit time in the sun especially from 10a.m - 2 p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses
Any Questions?

818-863-6299

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Water Resistant 80 minutes.

Package Labeling:

Active Ingredients

Zinc Oxide 12%

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capris Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Malus Domestica (Apple) Extract Phenoxyethanol, Plankton Extract, Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Potassium Sorbate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Squalane, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol

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:)

Rash or irritation develops and lasts

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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 way.


Advanced Ingredient Data


Raw Label Data

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