FDA.reportPublic FDA data

Sunscreen Cream

Manufacturer
Shenzhen Furuizhilian keji Co., Ltd.
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:21

Label at a glance#

ProductSunscreen Cream
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%

OTC - PURPOSE SECTION

Sunscreen

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 SECTION

For external use only

OTC - STOP USE SECTION

rash occurs

OTC - DO NOT USE SECTION

on damaged or broken skin

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remone

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

INACTIVE INGREDIENT SECTION

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Dicaprylyl Carbonate, Diethylhexyl Butamido Triazone, Titanium Dioxide, C20-22 Alkyl Phosphate, Aluminum Starch Octenylsuccinate, C20-22 Alcohols, Arginine, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Stearoyl Glutamate, Sodium Hydroxide, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Allantoin, Caprylyl Glycol, Tocopherol (Vitamin E), Stearyl Glycyrrhetinate, Polysorbate 60, Disodium EDTA, Fragrance, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Extract, Glucose, Potassium Sorbate

DOSAGE & ADMINISTRATION SECTION

Use when going out

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84445-005-012025-07-29C16284748780-13b156c62-28a9-fb37-e063-e6dba90a4e07Sunscreen Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84445-005-01Sunscreen Cream50 g in 1 TUBELOTION, AUGMENTED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84445-005SUNSCREEN CREAM (AVOBENZONE , HOMOSALATE ,OCTISALATE , OCTOCRYLENE) LOTION, AUGMENTED [SHENZHEN FURUIZHILIAN KEJI CO., LTD.]11 package rows20240717_1d5866a3-b480-eab6-e063-6294a90accb1.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84445-00584445-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
C20-22 ALCOHOLSO4M0347C6AIACT
SODIUM HYDROXIDE55X04QC32IIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%)8Z5ZAL5H3VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
BEMOTRIZINOLPWZ1720CBHIACT
ARGININE94ZLA3W45FIACT
PENTYLENE GLYCOL50C1307PZGIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
COCOAD9108TZ9KGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISCOTRIZINOL2UTZ0QC864IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
OCTINOXATE4Y5P7MUD51IACT
ENSULIZOLE9YQ9DI1W42IACT
XANTHAN GUMTTV12P4NEEIACT
ALLANTOIN344S277G0ZIACT
FRAGRANCE 135765EM498GW35IACT
POLYSORBATE 60CAL22UVI4MIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SQUALANEGW89575KF9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
1d5866a3-b481-eab6-e063-6294a90accb11d5866a3-b480-eab6-e063-6294a90accb12024-07-16WarningsExact identifier
spl id: 1d5866a3-b481-eab6-e063-6294a90accb1
spl set id: 1d5866a3-b480-eab6-e063-6294a90accb1

Reported adverse events (FAERS/openFDA)#

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