Dermaka Broad Spectrum Spf-42 Sunscreen Untinted

Dermaka Broad Spectrum Spf-42 Sunscreen Untinted
SPL v2
SPL
SPL Set ID 9aa24e1f-e338-4947-a437-554fb6b227a2
Route
TOPICAL
Published
Effective Date 2023-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation (110 mg)
Inactive Ingredients
Aloe Vera Leaf Water Bromelains Butyloctyl Salicylate Green Tea Leaf Medium-chain Triglycerides Caprylyl/capryl Oligoglucoside Cetostearyl Alcohol Citric Acid Monohydrate Chamomile Watermelon Coconut Dodecane Glycerin Glyceryl Caprylate Licorice Helianthus Annuus Flowering Top Hydroxyethyl Cellulose, Unspecified Stearic Acid .alpha.-tocopherol Acetate Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-02
Description

Titanium dioxide 6.00% Zinc Oxide 11.00%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 6.00% Zinc Oxide 11.00%

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Warnings:

not intended for ingestion. For external use only

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
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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 11.00%

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, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Citric Acid, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Gleceryl Stearate, Glyceryl Undecylenate, Glyyrrhiza Glabra (Licorice) Extract, Hawthorn Exract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, 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.

Pregnant Or Breastfeeding.

Stop Use and Ask A Doctor If

rash or irritation develops and lasts.

Consult your doctor before use if 

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 ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Purpose

Sunscreen

Warnings: (WARNINGS:)

not intended for ingestion. For external use only

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
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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 11.00%

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, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Citric Acid, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Gleceryl Stearate, Glyceryl Undecylenate, Glyyrrhiza Glabra (Licorice) Extract, Hawthorn Exract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, 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.

Pregnant Or Breastfeeding. (Pregnant or breastfeeding.)

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

rash or irritation develops and lasts.

Consult your doctor before use if 

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: 2026-02-15T12:02:21.480451 · Updated: 2026-03-14T23:01:51.692931