FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
Gaozhou Chapin Technology Co., Ltd
Effective date
2024-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:13

Label at a glance#

ProductSUNSCREEN
Active ingredientOCTISALATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

● helps prevent sunburn
● 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

Forexternal use only

Do not use

OTC - STOP USE SECTION

■On irritated skin and any area that is infected or reddened.
■If pregnant or if there is any allergic reaction to this product.

When Using

OTC - WHEN USING SECTION

avoid contact witheyes

Stop Use

OTC - STOP USE SECTION

If discomfort persists.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■If product gets into eyes, flush with water for 15 minutes
■If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

INACTIVE INGREDIENT SECTION

GLYCERYL MONOSTEARATE,2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW),DIETHYLHEXYL SYRINGYLIDENEMALONATE,CAPRYLYL GLYCOL,CHLORPHENESIN,EDETATE DISODIUM ANHYDROUS,BEHENYL ACRYLATE POLYMER,POLYOXYL 100 STEARATE,TOCOPHEROL,TROLAMINE,SENNA ALATA LEAF,GLYCERIN,DIMETHICONE,ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) ,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S),XANTHAN GUM,WATER,POTASSIUM CETYL PHOSPHATE ,PANTHENOL ,PEG-8 LAURATE,INULIN LAURYL CARBAMATE,P-ANISIC ACID,MEDIUM-CHAIN TRIGLYCERIDES,MALTODEXTRIN,SODIUM DODECYLBENZENESULFONATE,POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ,SILICON DIOXIDE,CAPRYLYL TRISILOXANE,PHENOXYETHANOL

DOSAGE & ADMINISTRATION SECTION

Apply according to actual needs each time. Each 100ml contains Avobenzone 3g, Homosalate 15%, Octisalate 5%, Octocrylene 10%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84168-050-052025-07-29C16284748780-13b156c62-2d11-fb37-e063-e6dba90a4e071e76413d-848e-21ee-e063-6394a90ac9e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84168-050-05SUNSCREEN50 mL in 1 BOTTLE, PLASTICCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84168-050SUNSCREEN CREAM [GAOZHOU CHAPIN TECHNOLOGY CO., LTD]11 package rows20240731_1e76413d-848e-21ee-e063-6394a90ac9e0.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84168-05084168-050-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
SENNA ALATA LEAF4BXR6YZN92IACT
ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW)3K8D4YRM4RIACT
PEG-8 LAURATE762O8IWA10IACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
HOMOSALATEV06SV4M95SACTIB
P-ANISIC ACID4SB6Y7DMM3IACT
WATER059QF0KO0RIACT
POLYOXYL 100 STEARATE TYPE ITQ9XS676NNIACT
PANTHENOLWV9CM0O67ZIACT
TOCOPHEROLR0ZB2556P8IACT
OCTOCRYLENE5A68WGF6WMACTIB
TROLAMINE9O3K93S3TKIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
DIMETHICONE92RU3N3Y1OIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
BEHENYL ACRYLATE POLYMERD64PM5UT4UIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
XANTHAN GUMTTV12P4NEEIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%)YY2HMJ9NZFIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
GLYCERINPDC6A3C0OXIACT
INULIN LAURYL CARBAMATE48RFF58ESGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB

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
1e76413d-848f-21ee-e063-6394a90ac9e01e76413d-848e-21ee-e063-6394a90ac9e02024-07-30WarningsExact identifier
spl id: 1e76413d-848f-21ee-e063-6394a90ac9e0
spl set id: 1e76413d-848e-21ee-e063-6394a90ac9e0

Reported adverse events (FAERS/openFDA)#

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