Dermaka Sunscreen Spf 42, Tinted

Dermaka Sunscreen Spf 42, Tinted
SPL v1
SPL
SPL Set ID 9a967cd1-9eec-4255-b14b-ac2e33e4dbf0
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ci 77891 (60 mg) Zinc Cation (77 mg)
Inactive Ingredients
Aloe Vera Leaf Juice Water Bromelain Butyloctyl Salicylate Green Tea Leaf Medium-chain Triglycerides Caprylyl/capryl Oligoglucoside Cetostearyl Alcohol Coconut Oil Dodecane Glycerin Glyceryl Monocaprylate Glyceryl Stearate Se Helianthus Annuus Flowering Top Hydroxyethyl Cellulose, Unspecified Ferric Oxide Red Stearic Acid .alpha.-tocopherol Acetate Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-03
Description

Titanium Dioxide 6.00 % Zinc Oxide 7.70 %

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 6.00 % Zinc Oxide 7.70 %

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
Warnings:

For external use onlynot intended for ingestion.

Drug Facts

Do Not Use

on damaged or broken skin.

Questions?

(772) 266-3376

Directions:
  • Apply liberally 15 minutes before sun exposure.
  • 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 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.
Package Labeling:

Active Ingredients

Titanium Dioxide 6.00 %

Zinc Oxide 7.70 %

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), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Caprylyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hawthorn Extract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Iron Oxides (Black, Red, White, Yellow), Polyhydroxystearic Acid, Sambucus Nigra (Elderberry) Extract, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

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.

Keep Out of Reach of Children.

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

Structured Label Content

Uses: (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

Warnings: (WARNINGS:)

For external use onlynot intended for ingestion.

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)

on damaged or broken skin.

Questions?

(772) 266-3376

Directions: (DIRECTIONS:)
  • Apply liberally 15 minutes before sun exposure.
  • 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 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.
Package Labeling:

Active Ingredients

Titanium Dioxide 6.00 %

Zinc Oxide 7.70 %

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

Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Caprylyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hawthorn Extract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Iron Oxides (Black, Red, White, Yellow), Polyhydroxystearic Acid, Sambucus Nigra (Elderberry) Extract, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), 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 If (Stop use and ask a doctor if)

rash or irritation develops and lasts.

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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:19.639922 · Updated: 2026-03-14T23:09:01.566522