FDA.reportPublic FDA data

Reflecting Mineral Sunscreen

Manufacturer
Helande, LLC | Island Kinetics, Inc. d.b.a. CoValence Laboratories
Effective date
2025-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:03

Label at a glance#

ProductReflecting Mineral Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Dosage and administration

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: Lim...

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2.35%, Zinc Oxide 13.5%

Purpose:

OTC - PURPOSE SECTION

Sunscreen.

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Use(s):

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

  • 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:

DOSAGE & ADMINISTRATION SECTION

  • 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:

INACTIVE INGREDIENT SECTION

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:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85767-610-01Reflecting Mineral Sunscreen30 mL in 1 BOTTLE, PLASTICLOTION301
85767-610-01Reflecting Mineral Sunscreen1 in 1 BOXLOTION11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85767-61085767-610-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYSORBATE 60CAL22UVI4MIACT
ETHYLHEXYL PALMITATE2865993309IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PHYMATOLITHON CALCAREUM6J1M3WA0ZKIACT
DIMETHYLMETHOXY CHROMANOLXBH432G01FIACT
POLLIA CONDENSATA FRUITA3VS3MTE73IACT
ISOSTEARIC ACIDX33R8U0062IACT
COENOCHLORIS SIGNIENSISG5P2RJVPDJIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
COCO-GLUCOSIDEICS790225BIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ERGOTHIONEINEBDZ3DQM98WIACT
ZINC SULFATE89DS0H96TBIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM GLUCONATER6Q3791S76IACT
WATER059QF0KO0RIACT
GALACTOARABINANSL4SX1O487IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
MANNITOL3OWL53L36AIACT
ALUMINALMI26O6933IACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLYL GLYCOL00YIU5438UIACT
STEARIC ACID4ELV7Z65APIACT
TROPOLONE7L6DL16P1TIACT
BENZYL ALCOHOLLKG8494WBHIACT
BISABOLOL24WE03BX2TIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
ndc (package): 85767-610-01
ndc (product): 85767-610
ndc11 (package): 85767061001
spl id: 3750f04b-7fa0-8793-e063-6294a90a9143
spl set id: 3750f04b-7f9f-8793-e063-6294a90a9143

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.