Label: THE MINERAL MELT SPF30- zinc oxide, titanium dioxide lotion
- NDC Code(s): 82757-102-10, 82757-103-10
- Packager: Dune Suncare Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 1, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
-
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
-
Directions
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating:
- immediately after towel drying
- at least every 2 hours.
- 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive Ingredients
Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Maltodextrin, Polyester-8, Benzyl Alcohol, Sodium Acrylate/Sodium Acryloylddimethyl Taurate Copolymer, Hydrogenated Lecithin, Glyceryl Caprylate, C15-19 Alkane, Silica, Polyhydroxystearic Acid, Alumina, Stearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Polyglyceryl-6 Laurate, Caprylhydroxamic Acid, Sodium Hydroxide, Carnosine, Polyglycerin-6, Canola Oil, Sorbitan Oleate, Caesalpinia Spinosa Fruit Pod Extract, Sorbitan Isostearate, Cistus Monspeliensis Extract, Helianthus Annuus (Sunflower) Sprout Extract, Daucus Carota Sativa (Carrot) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Beta-Carotene, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate
- Principal Display Panel – 50 mL Bottle Label
- Principal Display Panel – 2 mL Packet Label
-
INGREDIENTS AND APPEARANCE
THE MINERAL MELT SPF30
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82757-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 48 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 23 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glycerin (UNII: PDC6A3C0OX) Dimethicone (UNII: 92RU3N3Y1O) Maltodextrin (UNII: 7CVR7L4A2D) Polyester-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Benzyl Alcohol (UNII: LKG8494WBH) Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX) Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N) Glyceryl Monocaprylate (UNII: TM2TZD4G4A) C15-19 Alkane (UNII: CI87N1IM01) Silicon Dioxide (UNII: ETJ7Z6XBU4) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Aluminum Oxide (UNII: LMI26O6933) Stearic Acid (UNII: 4ELV7Z65AP) Xanthan Gum (UNII: TTV12P4NEE) Triethoxycaprylylsilane (UNII: LDC331P08E) Polyglyceryl-6 Laurate (UNII: Q48X4BL3TV) Caprylhydroxamic Acid (UNII: UPY805K99W) Sodium Hydroxide (UNII: 55X04QC32I) Caesalpinia Spinosa Fruit Pod (UNII: EXY4496LWD) Carnosine (UNII: 8HO6PVN24W) Polyglycerin-6 (UNII: M51422LRAM) Canola Oil (UNII: 331KBJ17RK) Sorbitan Monooleate (UNII: 06XEA2VD56) Sorbitan Isostearate (UNII: 01S2G2C1E4) Helianthus Annuus Sprout (UNII: 4P26HG1S5W) Cistus Monspeliensis Whole (UNII: T2OG06826L) Carrot (UNII: L56Z1JK48B) Carrot Seed Oil (UNII: 595AO13F11) Beta Carotene (UNII: 01YAE03M7J) Sunflower Oil (UNII: 3W1JG795YI) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82757-102-10 50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 06/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/01/2023 THE MINERAL MELT SPF30
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82757-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 48 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 23 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glycerin (UNII: PDC6A3C0OX) Dimethicone (UNII: 92RU3N3Y1O) Maltodextrin (UNII: 7CVR7L4A2D) Polyester-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Benzyl Alcohol (UNII: LKG8494WBH) Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX) Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N) Glyceryl Monocaprylate (UNII: TM2TZD4G4A) C15-19 Alkane (UNII: CI87N1IM01) Silicon Dioxide (UNII: ETJ7Z6XBU4) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Aluminum Oxide (UNII: LMI26O6933) Stearic Acid (UNII: 4ELV7Z65AP) Xanthan Gum (UNII: TTV12P4NEE) Triethoxycaprylylsilane (UNII: LDC331P08E) Polyglyceryl-6 Laurate (UNII: Q48X4BL3TV) Caprylhydroxamic Acid (UNII: UPY805K99W) Sodium Hydroxide (UNII: 55X04QC32I) Caesalpinia Spinosa Fruit Pod (UNII: EXY4496LWD) Carnosine (UNII: 8HO6PVN24W) Polyglycerin-6 (UNII: M51422LRAM) Canola Oil (UNII: 331KBJ17RK) Sorbitan Monooleate (UNII: 06XEA2VD56) Sorbitan Isostearate (UNII: 01S2G2C1E4) Helianthus Annuus Sprout (UNII: 4P26HG1S5W) Cistus Monspeliensis Whole (UNII: T2OG06826L) Carrot (UNII: L56Z1JK48B) Carrot Seed Oil (UNII: 595AO13F11) Beta Carotene (UNII: 01YAE03M7J) Sunflower Oil (UNII: 3W1JG795YI) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82757-103-10 2 mL in 1 PACKET; Type 0: Not a Combination Product 06/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/01/2023 Labeler - Dune Suncare Inc. (049095642)
