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PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1

PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1

Approved
Approval ID

18130858-429c-4ed4-a75b-5bc014481250

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 4, 2025

Manufacturers
FDA

Hangzhou Jingshen Trading Co., Ltd.

DUNS: 616067829

Products 1

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

ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87080-000
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 4, 2025
FDA Product Classification

INGREDIENTS (28)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
PHENYL TRIMETHICONEInactive
Code: DR0K5NOJ4R
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
CYCLOMETHICONE 5Inactive
Code: 0THT5PCI0R
Classification: IACT
POLYGLYCERYL-3 DIISOSTEARATEInactive
Code: 46P231IQV8
Classification: IACT
SORBITAN ISOSTEARATEInactive
Code: 01S2G2C1E4
Classification: IACT
TRIDECYL TRIMELLITATEInactive
Code: FY36J270ES
Classification: IACT
DIISOSTEARYL MALATEInactive
Code: QBS8A3XZGQ
Classification: IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEInactive
Code: 9229XJ4V12
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMInactive
Code: DE08037SAB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ENSULIZOLEActive
Quantity: 20 mg in 1 mL
Code: 9YQ9DI1W42
Classification: ACTIB
HOMOSALATEActive
Quantity: 50 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTINOXATEActive
Quantity: 49.95 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
TITANIUM DIOXIDEActive
Quantity: 124.475 mg in 1 mL
Code: 15FIX9V2JP
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/4/2025

Package Labeling:

Outer PackageInner Package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/4/2025

Uses

  • helps prevent sunburn
  • provides high protection against sunburn and tanning
  • lf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

LOINC: 34071-1Updated: 9/4/2025

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 lf

  • rash or irritation develops and lasts

keep out of reach if children.

if product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2025

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months :Ask a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/4/2025

Other information

protect the product in this container from excessive heat and direct sun

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/4/2025

Active ingredients

Ensulizole 2%, Homosalate 5%, Octinoxate 4.995%, Titanium Dioxide 12.4475%

Purpose

Suscreen

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2025

Inactive ingredients

Water, Silica, Glycerin, C12-15 Alkyl Benzoate, Phenyl Trimethicone, Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Sorbitan Isostearate, Tridecyl Trimellitate, Diisostearyl Malate, Polyglyceryl-2 Dipolyhydroxystearate, Triethoxycaprylylsilane, Phenoxyethanol, Disteardimonium Hectorite, Alumina, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride, Sodium Hydroxide, Fragrance, Ethylhexylglycerin, BHT, lron Oxides (Cl77492, CI 77491, CI 77499)

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/4/2025

Questions or comments?

Call1-818-579-7288or1-818-688-3208WWW.PHOFAY.COM

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PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1 - FDA Drug Approval Details