theraderm platinum protection facial sunscreen spf 40

theraderm platinum protection facial sunscreen spf 40
SPL v1
SPL
SPL Set ID 1fea6ad8-4d33-4f7c-800c-1bee644bd97f
Route
topical
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (100 mg) ethylhexyl salicylate (50 mg) zinc cation (40 mg)
Inactive Ingredients
allantoin aloe vera leaf water ascorbyl palmitate butyloctyl salicylate green tea leaf medium-chain triglycerides cetostearyl alcohol cetearyl glucoside cetyl alcohol citric acid monohydrate coconut oil ethylhexylglycerin glyceryl stearate se isododecane c13-14 isoparaffin laureth-7 panthenol phenoxyethanol polysorbate 20 sodium hyaluronate squalane stearyl alcohol .alpha.-tocopherol acetate corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-01

Purpose

Sunscreen

Description

Octocrylene 10.00% Octisalate 5.00% Zinc oxide 4.00%


Medication Information

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. 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

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, and at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: 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: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. 

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl Stearate SE, Isododecane, C13-14 Isoparaffin, Laureth-7, dl-Panthenol, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Sodium Hyaluronate, Squalane, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Zemea (Corn) Propanediol.

Description

Octocrylene 10.00% Octisalate 5.00% Zinc oxide 4.00%

Do Not Use
  • on damaged or broken skin.
Active Ingredients

Octocrylene 10.00%

Octisalate 5.00%

Zinc oxide 4.00%

Package Labeling: 20ml

Package Labeling: 118ml

When Using this Product
  • keep out of eyes. • Rinse with water to remove.• Do not puncture or incinerate. Contents underpressure. • Do not store it at temperatures above 120°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. 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

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, and at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: 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: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. 

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl Stearate SE, Isododecane, C13-14 Isoparaffin, Laureth-7, dl-Panthenol, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Sodium Hyaluronate, Squalane, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Zemea (Corn) Propanediol.

Do Not Use (Do not use)
  • on damaged or broken skin.
Active Ingredients

Octocrylene 10.00%

Octisalate 5.00%

Zinc oxide 4.00%

Package Labeling: 20ml

Package Labeling: 118ml

When Using this Product (When using this product)
  • keep out of eyes. • Rinse with water to remove.• Do not puncture or incinerate. Contents underpressure. • Do not store it at temperatures above 120°F.
Stop Use and Ask A Doctor (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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