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SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40

SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40

Approved
Approval ID

9ffbd53b-1295-42b4-9cd5-18cbb75921d0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

ALL THE RAJE, LLC

DUNS: 007761894

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87018-875
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (35)

DODECANEInactive
Code: 11A386X1QH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL STEARATE CITRATEInactive
Code: WH8T92A065
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
HEPTYL UNDECYLENATEInactive
Code: W77QUB6GXO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOAMYL LAURATEInactive
Code: M1SLX00M3M
Classification: IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATEInactive
Code: D2QHA03458
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
OPUNTIA STREPTACANTHA STEMInactive
Code: 3TF9Z1U73O
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
SORBITAN STEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TRIDECYL SALICYLATEInactive
Code: AZQ08K38Z1
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ZINC OXIDEActive
Quantity: 150 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIM
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
C13-16 ISOPARAFFINInactive
Code: LED42LZG6O
Classification: IACT
CAMELLIA OLEIFERA LEAFInactive
Code: 5077EL0C60
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSInactive
Code: 4YS74Q4G4J
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DECYL GLUCOSIDEInactive
Code: Z17H97EA6Y
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/13/2025

Package Labeling:

Outer PackageInner Package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/13/2025

Other information

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active Ingredients

Zinc Oxide 15.00%

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2025

Directions

  • 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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/13/2025

Questions?

Please visitsolmiragesuncare.com

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SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40 - FDA Drug Approval Details