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Moisturizing and Translucent Sunscreen

85594-003-01 Moisturizing and Translucent Sunscreen

Approved
Approval ID

34e71939-ca70-b5b7-e063-6394a90a30b8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 11, 2025

Manufacturers
FDA

Dongguan Haiyi Cosmetics Co., Ltd.

DUNS: 570250975

Products 1

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

Sunscreen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85594-003
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sunscreen
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateMay 11, 2025
FDA Product Classification

INGREDIENTS (5)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HOUTTUYNIA CORDATA WHOLEActive
Quantity: 6 mg in 100 mL
Code: O3E12ZLW5T
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/11/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/11/2025

Clean the face, apply the sunscreen evenly on the face,and gently massage until it is completely absorbed.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/11/2025

Houttuynia cordata extract

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Water / Glycerol / Houttuynia cordata extract /Titanium dioxide / Tocopherol

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/11/2025

■ Provides sun protection and reduces UV damage to skin
■ The texture is moist and light,clear andranslucent
■Breathable, not easy to remove makeup, delicate makeup, Easy to remove makeup

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

1.For external use only

2.When using this product, avoidcontact with the eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/11/2025

lf discomfortor sensitivity to product occurs,please discont inue use and consult a physician

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/11/2025

Not suitable for use by children, pregnantor breast feeding people.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/11/2025

KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/11/2025

Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.

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Moisturizing and Translucent Sunscreen - FDA Drug Approval Details