FDA.reportPublic FDA data

SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40

Manufacturer
ALL THE RAJE, LLC | Pure Source, LLC
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:25

Label at a glance#

ProductSM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. higher SPF gives more sunburn protection 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 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection me...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Bisabolol, Ascorbic Acid, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C13-16 Isoalkane, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Caramel, Centella Asiatica Extract, Citric Acid, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Heptyl Undecylenate, Hydrolyzed Silk, Iron Oxides (CI 77491) (CI 77492), Isoamyl Laurate, Leconostoc/Radish Root Ferment Filtrate, Niacinamide, Opuntia Streptacantha Stem Extract, Panthenol, Polyhydroxystearic Acid, Propanediol, Sodium Hyaluronate, Sorbitan Stearate, Squalane, Tocopheryl Acetate, Tridecyl Salicylate, Triethoxycaprylylsilane, Water (Aqua), Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

Please visit solmiragesuncare.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87018-875-00SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 4050 mL in 1 BOTTLELIQUID501
87018-875-00SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 401 in 1 BOXLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87018-87587018-875-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ISOAMYL LAURATEM1SLX00M3MIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
NIACINAMIDE25X51I8RD4IACT
OPUNTIA STREPTACANTHA STEM3TF9Z1U73OIACT
PANTHENOLWV9CM0O67ZIACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SORBITAN STEARATENVZ4I0H58XIACT
SQUALANEGW89575KF9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
BISABOLOL24WE03BX2TIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
C13-16 ISOPARAFFINLED42LZG6OIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARAMELT9D99G2B1RIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DECYL GLUCOSIDEZ17H97EA6YIACT

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
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40ZINC OXIDEALL THE RAJE, LLC9ffbd53b-1295-42b4-9cd5-18cbb75921d02025-08-13WarningsExact identifier
ndc (package): 87018-875-00
ndc (product): 87018-875
ndc11 (package): 87018087500
spl id: 3c401a7d-6e6e-800e-e063-6394a90a3c49
spl set id: 9ffbd53b-1295-42b4-9cd5-18cbb75921d0

Reported adverse events (FAERS/openFDA)#

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