THE MINERAL MELT SPF30- zinc oxide, titanium dioxide lotion

The Mineral Melt SPF30 by

Drug Labeling and Warnings

The Mineral Melt SPF30 by is a Otc medication manufactured, distributed, or labeled by Dune Suncare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide, 2.3%

Zinc oxide, 4.8%

Purpose

Sunscreen

Sunscreen

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

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

• 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
• 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

• protect the product in this container from excessive heat and direct sun

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 – 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

INGREDIENTS AND APPEARANCE

THE MINERAL MELT SPF30 
zinc oxide, titanium dioxide lotion

Product 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 lotion

Product 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)