Dermacin ®

Dermacin ®
SPL v5
SPL
SPL Set ID 86eb06cc-d63f-4500-a52e-14ef99a56532
Route
TOPICAL
Published
Effective Date 2019-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25 mg) Octinoxate (30 mg) Octisalate (12.5 mg) Titanium Dioxide
Inactive Ingredients
Water Polawax Polysorbate Shea Butter Stearic Acid Ethylhexyl Palmitate Phenoxyethanol Benzoic Acid Dehydroacetic Acid Sunflower Oil Isopropyl Isostearate .alpha.-tocopherol Potassium Sorbate Xanthan Gum Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-16
Description

Avobenzone 2.5% Octinoxate 3% Octisalate 3% Titanium Dioxide 1.25%

Purpose

Sunscreen (Avobenzone 2.5%) Sunscreen (Octinoxate 3%) Sunscreen (Octisalate 3%) Sunscreen (Titanium Dioxide 1.25%) 

Medication Information

Purpose

Sunscreen (Avobenzone 2.5%) Sunscreen (Octinoxate 3%) Sunscreen (Octisalate 3%) Sunscreen (Titanium Dioxide 1.25%) 

Description

Avobenzone 2.5% Octinoxate 3% Octisalate 3% Titanium Dioxide 1.25%

Uses

■ Helps prevent sunburn.

■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.   

Purposes

Sunscreen (Avobenzone 2.5%)

Sunscreen (Octinoxate 3%)

Sunscreen (Octisalate 3%)

Sunscreen (Titanium Dioxide 1.25%) 

Warnings

For external use only

Directions

■ Apply liberally 15 minutes before sun exposure ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying   

■ Reaply: ■ 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 the risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats, and sunglasses. ■ Children under six months of age: Ask a doctor.

Do Not Use

■ on damaged or broken skin

Questions?

1.800.611.4270 

Dermacin ®

DISTRIBUTED BY:

PureTek Corporation

San Fernando, CA 91340

Other Information

■ Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Emulsifying Wax, Shea butter, Stearic Acid, Ethylhexyl Palmitate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Sunflower Seed Oil, Isopropyl Isostearate, Vitamin E, Potassium Sorbate, Xanthan Gum, Sodium Benzoate.

When Using This Product

■ keep out of eyes

■ Rinse with water to remove

Active Ingredients (% W/w)

Avobenzone 2.5%

Octinoxate 3%

Octisalate 3%

Titanium Dioxide 1.25%

Stop Use and Ask A Doctor If

■ rash occurs

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

■ Helps prevent sunburn.

■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.   

Purposes

Sunscreen (Avobenzone 2.5%)

Sunscreen (Octinoxate 3%)

Sunscreen (Octisalate 3%)

Sunscreen (Titanium Dioxide 1.25%) 

Warnings

For external use only

Directions

■ Apply liberally 15 minutes before sun exposure ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying   

■ Reaply: ■ 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 the risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats, and sunglasses. ■ Children under six months of age: Ask a doctor.

Do Not Use (Do not use)

■ on damaged or broken skin

Questions?

1.800.611.4270 

Dermacin ®

DISTRIBUTED BY:

PureTek Corporation

San Fernando, CA 91340

Other Information (Other information)

■ Protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Emulsifying Wax, Shea butter, Stearic Acid, Ethylhexyl Palmitate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Sunflower Seed Oil, Isopropyl Isostearate, Vitamin E, Potassium Sorbate, Xanthan Gum, Sodium Benzoate.

When Using This Product (When using this product)

■ keep out of eyes

■ Rinse with water to remove

Active Ingredients (% W/w) (Active ingredients (% w/w))

Avobenzone 2.5%

Octinoxate 3%

Octisalate 3%

Titanium Dioxide 1.25%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.114034 · Updated: 2026-03-14T23:03:50.462651