Skinsuit Tm 3 In 1 Moisturizer Spf 50

Skinsuit Tm 3 In 1 Moisturizer Spf 50
SPL v1
SPL
SPL Set ID 5eb27be9-9e80-4f4a-b193-b918d831555d
Route
TOPICAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (175 mg)
Inactive Ingredients
Adansonia Digitata Seed Oil Aloe Vera Leaf Juice Shea Butter C12-15 Alkyl Benzoate Green Tea Leaf Medium-chain Triglycerides Safflower Oil Cetostearyl Alcohol Cetearyl Glucoside Citric Acid Monohydrate Coconut Oil Cucumber Daucus Carota Subsp. Sativus Seed Decyl Glucoside Dodecane Glycerin Glyceryl Monocaprylate Mangifera Indica Seed Butter Avocado Oil Propanediol Pomegranate Sodium Stearoyl Glutamate Stearic Acid Tocopherol Tridecyl Salicylate Blueberry Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-26

Description

Zinc Oxide 17.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 17.5%

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 sun
Warnings:

For external use only

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

Questions?

(760) 268-0047

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
  • 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. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Active Ingredient

Zinc Oxide 17.5%

Other Information
  • Protect container from excessive heat and direct sun.
Inactive Ingredients:

Adansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid, Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum.

Package Labeling: 90ml

Package Labeling: 177ml

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • Do not store it at temperatures above 120º F.
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 sun
Purpose

Sunscreen

Warnings:

For external use only

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

Questions?

(760) 268-0047

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
  • 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. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Active Ingredient

Zinc Oxide 17.5%

Other Information
  • Protect container from excessive heat and direct sun.
Inactive Ingredients:

Adansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid, Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum.

Package Labeling: 90ml

Package Labeling: 177ml

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • Do not store it at temperatures above 120º F.
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

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