DERMAKA SUNSCREEN SPF 42, TINTED- titanium dioxide, zinc oxide cream

Dermaka Sunscreen SPF 42, Tinted by

Drug Labeling and Warnings

Dermaka Sunscreen SPF 42, Tinted by is a Otc medication manufactured, distributed, or labeled by DERMAKA SKIN PRODUCTS, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Titanium Dioxide 6.00 %
Zinc Oxide 7.70 %

Purpose

Sunscreen

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.

Do not use

on damaged or broken skin.

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.

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.

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.

Questions?

(772) 266-3376

Package Labeling:

INGREDIENTS AND APPEARANCE

DERMAKA SUNSCREEN SPF 42, TINTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82240-619
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	77 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
WATER (UNII: 059QF0KO0R)
BROMELAIN (UNII: U182GP2CF3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCONUT OIL (UNII: Q9L0O73W7L)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82240-619-00	5 mL in 1 PACKET; Type 0: Not a Combination Product	06/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/03/2025

Labeler - DERMAKA SKIN PRODUCTS (087218113)

Registrant - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(82240-619)