REFLECTING MINERAL SUNSCREEN- zinc oxide, titanium dioxide lotion

Reflecting Mineral Sunscreen by

Drug Labeling and Warnings

Reflecting Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Helande, LLC, Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Titanium Dioxide 2.35%, Zinc Oxide 13.5%

Purpose:

Sunscreen.

WARNINGS

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

Use(s):

• 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:

• Shake well before use.
• Apply liberally and evenly 15 minutes before sun exposure.
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• 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 a broad-spectrum SPF of 15 or higher and other sun protection measures including:

• Limit time in the sun especially from 10a.m.-2p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: Ask a doctor.

Inactive Ingredients:

Aqua (Water), C12-15 Alkyl Benzoate, Glycerin, Galactoarabinan, Ethylhexyl Palmitate, Argania Spinosa Kernel Oil, Tocopheryl Acetate (D-alpha), Caprylic/Capric Triglyceride, Polysorbate 60, Lithothamnion Calcareum Powder, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Phenoxyethanol, Isostearic Acid, Coco-Glucoside, Xanthan Gum, Mannitol, Benzyl Alcohol, 1,2-Hexanediol, Caprylyl Glycol, Polyhydroxystearic Acid, Bisabolol (L-alpha), Alumina, Stearic Acid, Sodium Gluconate, Diatomaceous Earth, Caprylhydroxamic Acid, Ethylhexylglycerin, Zinc Sulfate, Tropolone, Maltodextrin, Camellia Sinensis (Green Tea) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Dimethylmethoxy Chromanol, Pollia Condensata Fruit Extract, Coenochloris Signiensis Extract, Lecithin, Ergothioneine

Other Information:

• Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REFLECTING MINERAL SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85767-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.135 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.023 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
POLLIA CONDENSATA FRUIT (UNII: A3VS3MTE73)
ISOSTEARIC ACID (UNII: X33R8U0062)
COENOCHLORIS SIGNIENSIS (UNII: G5P2RJVPDJ)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
COCO-GLUCOSIDE (UNII: ICS790225B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ZINC SULFATE (UNII: 89DS0H96TB)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
GALACTOARABINAN (UNII: SL4SX1O487)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
MANNITOL (UNII: 3OWL53L36A)
ALUMINA (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROPOLONE (UNII: 7L6DL16P1T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BISABOLOL (UNII: 24WE03BX2T)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85767-610-01	1 in 1 BOX	07/01/2025
1		30 mL in 1 BOTTLE, PLASTIC; 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	07/01/2025

Labeler - Helande, LLC (125307795)

Establishment
Name	Address	ID/FEI	Business Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories		959735002	manufacture(85767-610)