THE MINERAL MELT SPF30- zinc oxide, titanium dioxide lotion 
Dune Suncare Inc.

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Drug Facts

Active ingredients

Titanium dioxide, 2.3%

Zinc oxide, 4.8%

Purpose

Sunscreen

Sunscreen

Uses

Warnings

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 occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

DUNE

THE
MINERAL
MELT

INVISIBLE MINERAL
SUNCARE FOR FACE

BROAD SPECTRUM
SPF 30

Sheerest Mineral
Hydration
Enriched with Youth
Peptides
Non-Comedogenic
Fragrance Free

50 mL

1.7 FL OZ

Principal Display Panel – 50 mL Bottle Label

Principal Display Panel – 2 mL Packet Label

DUNE
SUNCARE

THE
MINERAL
MELT

INVISIBLE MINERAL
SUNCARE FOR
FACE

BROAD SPECTRUM
SPF 30

Doctor-Developed
Hydrating,
Brightening &
Firming
Non-Comedogenic
Fragrance Free

2 mL

0.067 FL OZ

Principal Display Panel – 2 mL Packet Label
THE MINERAL MELT SPF30 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82757-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide48 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide23 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82757-102-1050 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2023
THE MINERAL MELT SPF30 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82757-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide48 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide23 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82757-103-102 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2023
Labeler - Dune Suncare Inc. (049095642)

Revised: 6/2023
Document Id: cadc182a-cd3a-4c58-87b7-a968039d702b
Set id: 2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3
Version: 1
Effective Time: 20230601
 
Dune Suncare Inc.