FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
Guangzhou Yanxi Biotechnology Co., Ltd
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:47:12

Label at a glance#

ProductSUNSCREEN
Active ingredientGLYCERIN, BUTYLENE GLYCOL
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Apply freely 15 minutes prior to sun exposure, then reapply after 80 minutes of swimming or sweating and immediately after towel drying, and at least every 2 hours.

WARNINGS SECTION

Keep out of children

INACTIVE INGREDIENT SECTION

Aqua

INDICATIONS & USAGE SECTION

For daily skin care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children

OTC - PURPOSE SECTION

Refreshing & comfortable instant protection your skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84025-28984025-289

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84025-289-012026-01-29C16284748780-149896155-afe2-586f-e063-e6dba90add9029aee1b9-e7aa-bc08-e063-6294a90a236e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84025-289-01SUNSCREEN50 mL in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84025-289SUNSCREEN CREAM [GUANGZHOU YANXI BIOTECHNOLOGY CO., LTD]11 package rows20241222_29aee1b9-e7aa-bc08-e063-6294a90a236e.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84025-28984025-289-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAACTIB

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
29aee1b9-e7ab-bc08-e063-6294a90a236e29aee1b9-e7aa-bc08-e063-6294a90a236e2024-12-20WarningsExact identifier
spl id: 29aee1b9-e7ab-bc08-e063-6294a90a236e
spl set id: 29aee1b9-e7aa-bc08-e063-6294a90a236e