Label: DERMAKA BROAD SPECTRUM SPF-42 SUNSCREEN UNTINTED- titanium dioxide, zinc oxide cream
- NDC Code(s): 82240-424-00
- Packager: DERMAKA SKIN PRODUCTS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- USES:
- WARNINGS:
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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.
- Other Information:
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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.
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
DERMAKA BROAD SPECTRUM SPF-42 SUNSCREEN UNTINTED
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82240-424 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82240-424-00 100 mL in 1 TUBE; Type 0: Not a Combination Product 10/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/02/2023 Labeler - DERMAKA SKIN PRODUCTS (087218113)
