DERMAKA BROAD SPECTRUM SPF-42 SUNSCREEN UNTINTED- titanium dioxide, zinc oxide cream 
DERMAKA SKIN PRODUCTS

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DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted

DRUG FACTS

Active Ingredients

Titanium dioxide 6.00%

Zinc Oxide 11.00%

Purpose

Sunscreen

USES:

WARNINGS:

not intended for ingestion. For external use only

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.

Consult your doctor before use if 

Pregnant or breastfeeding.

Keep out of reach of children.

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

DIRECTIONS:

Other Information:

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.

Questions?

(772) 266-3376

Package Labeling:

Label

DERMAKA BROAD SPECTRUM SPF-42 SUNSCREEN UNTINTED 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82240-424
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION110 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BROMELAINS (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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CHAMOMILE (UNII: FGL3685T2X)  
WATERMELON (UNII: 231473QB6R)  
COCONUT (UNII: 3RT3536DHY)  
DODECANE (UNII: 11A386X1QH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
LICORICE (UNII: 61ZBX54883)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CORN (UNII: 0N8672707O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82240-424-00100 mL in 1 TUBE; Type 0: Not a Combination Product10/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/02/2023
Labeler - DERMAKA SKIN PRODUCTS (087218113)

Revised: 11/2023
Document Id: 09e30a62-356e-3cff-e063-6394a90a270f
Set id: 9aa24e1f-e338-4947-a437-554fb6b227a2
Version: 2
Effective Time: 20231111
 
DERMAKA SKIN PRODUCTS