Label: SUN DEFENSE MINERAL SUNSCREEN SPF 30 FACE- zinc oxide cream
- NDC Code(s): 54108-0420-1
- Packager: derma e
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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Uses
- Helps prevent sunburn
- 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
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Directions
- apply liberally 15 minutes before sun exposure
- Children under 6 months of age: Ask a doctor
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Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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-sleeve shirts, pants, hats, and sunglasses
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Other information
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Inactive Ingredients
Purified Water, Coco-Caprylate (Coconut Derived), Dicaprylyl Carbonate, Lauryl Glucoside (Plant Derived), Polyglyceryl-2 Dipolyhydroxystearate, Glycerin (Vegetable Derived), Microcrystalline Cellulose (Plant Derived), Cellulose Gum (Plant Derived), Organic Camellia Sinensis (Green Tea) Leaf Extract1, Panthenol (Provitamin B5), Sodium Ascorbyl Phosphate (Vitamin C),Tocopheryl Acetate (Vitamin E), Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol.
- 1
- Certified Organic Ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
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INGREDIENTS AND APPEARANCE
SUN DEFENSE MINERAL SUNSCREEN SPF 30 FACE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54108-0420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE (UNII: 4828G836N6) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M) PANTHENOL (UNII: WV9CM0O67Z) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) FYTIC ACID (UNII: 7IGF0S7R8I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54108-0420-1 1 in 1 CARTON 01/01/2016 1 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 01/01/2016 Labeler - derma e (148940450) Registrant - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topiderm, Inc. 049121643 MANUFACTURE(54108-0420)
