FDA.reportPublic FDA data

Mineral SPF 40 Moisturizer

Manufacturer
Mineral Fusion brands
Effective date
2019-09-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:37:34

Label at a glance#

ProductMineral SPF 40 Moisturizer
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and 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

Dosage and administration

Apply liberally to clean skin 15 minutes before sun exposure Reapply: after 40 minutes of swimming or sweating immediately after towel drying 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 tim...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 7.5%Sunscreen
Zinc Oxide 5.0%Sunscreen

Uses

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

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to clean skin 15 minutes before sun exposure
  • Reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • 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 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Water (Aqua), Aloe Barbadensis (Aloe Vera) Leaf Juice1 Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Vegetable Glycerin, Hexyl Laurate, Polyglyceryl-4 Isostearate, Cetyl Alcohol, Myristyl Myristate, Simmondsia Chinensis (Jojoba) Seed Oil1 Butyrospermum Parkii (Shea) Butter1, Panthenol, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Palmitoyl Pentapeptide-3, Cucumis Sativus (Cucumber) Fruit Extract1, Tocopherol Acetate, Allantoin, Soy Lecithin, Camellia Sinensis (Green Tea) Leaf Extract1, Sodium PCA, Hyaluronic Acid, Chamomilla Recutita (Matricaria) Flower Extract1, Rosmarinus Officinalis (Rosemary) Leaf Oil, Calendula Officinalis Flower Extract1, Cedrus Atlantica (Cedarwood) Bark Oil, Ginkgo Biloba Leaf Extract1, Alaria Esculenta (Sea Kelp) Extract, Pelargonium Graveolens (Geranium) Flower Oil, Magnesium Aluminum Silicate, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Natural Fragrance.

1 Certified Organic

Questions

OTC - QUESTIONS SECTION

Call 1-800-428-1668
Mon-Fri 8 a.m. – 5 p.m. PST

SPL UNCLASSIFIED SECTION

Dist. by Mineral Fusion
Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral SPF 40
Moisturizer

Nourishing Hydration
with Shea Butter
Broad Spectrum

MINERAL
FUSION®

Making
Beauty
Healthy®

Net Wt 3.4 oz e 96 g

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55789-3109-22025-01-30C16284748780-1ba0f9c33-46ad-a910-e053-dadaa90a0b85Mineral SPF 40 Moisturizer
55789-3109-22023-02-06C16284748780-1ba0f9c33-46ad-a910-e053-dadaa90a0b85Mineral SPF 40 Moisturizer
55789-3109-22021-01-29C16284748780-1ba0f9c33-46ad-a910-e053-dadaa90a0b85Mineral SPF 40 Moisturizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55789-3109MINERAL SPF 40 MOISTURIZER (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [MINERAL FUSION BRANDS]3Legacy NDC20230208_7b69df00-c899-4d48-beaa-2def9008dbf0.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55789-310955789-3109-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
GLYCERINPDC6A3C0OXIACT
HEXYL LAURATE4CG9F9W01QIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
SHEA BUTTERK49155WL9YIACT
PANTHENOLWV9CM0O67ZIACT
MAGNESIUM ASPARTATER17X820ROLIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
COPPER GLUCONATERV823G6G67IACT
HYALURONATE SODIUMYSE9PPT4THIACT
PALMITOYL PENTAPEPTIDE-4KK181SM5JGIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALLANTOIN344S277G0ZIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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
b361fc3e-f00c-4e2a-ab31-e27290203f517b69df00-c899-4d48-beaa-2def9008dbf02026-03-12WarningsExact identifier
spl set id: 7b69df00-c899-4d48-beaa-2def9008dbf0

Reported adverse events (FAERS/openFDA)#

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