FDA.reportPublic FDA data

ACTIBEAU Camellia Floral Calming Sunscreen

Manufacturer
ACTIVEBEUTY CO.,LTD
Effective date
2019-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:05

Label at a glance#

ProductACTIBEAU Camellia Floral Calming Sunscreen
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.2%
Titanium Dioxide 4.8184%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

WARNINGS SECTION

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 using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

WATER, BUTYLENE GLYCOL, DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, PROPANEDIOL, DIMETHICONE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, NIACINAMIDE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, POLYMETHYL METHACRYLATE, HYDROGENATED POLY(C6-14 OLEFIN), POTASSIUM CETYL PHOSPHATE, C14-22 ALCOHOLS, TREHALOSE, C12-15 ALKYL BENZOATE, CETEARYL ALCOHOL, PEG-100 STEARATE, BEHENYL ALCOHOL, PHENOXYETHANOL, FRAGRANCE, C12-20 ALKYL GLUCOSIDE, ALUMINUM HYDROXIDE, POLYGLYCERYL-6 POLYRICINOLEATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FERRIC OXIDE YELLOW (CI 77492), XANTHAN GUM, NEOPENTYL GLYCOL DIETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ADENOSINE, POTASSIUM HYDROXIDE, ETHYLHEXYLGLYCERIN, FERRIC OXIDE RED (CI 77491), DISODIUM EDTA, ZINC OXIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM HYALURONATE, CAMELLIA JAPONICA SEED OIL, D&C RED NO. 33 (CI 17200), NELUMBO NUCIFERA FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT, PRUNUS MUME FLOWER EXTRACT, PYRUS COMMUNIS (PEAR) FLOWER EXTRACT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73016-004-022021-01-29C16284748780-1ba0f9c33-4380-a910-e053-dadaa90a0b8573016-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73016-004-01ACTIBEAU Camellia Floral Calming Sunscreen50 mL in 1 CONTAINERCREAM501
73016-004-02ACTIBEAU Camellia Floral Calming Sunscreen1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73016-004ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ACTIVEBEUTY CO.,LTD]1Legacy NDC, 2 package rows20190404_61fabd61-c3f8-4045-a83d-3192bb2cb41a.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73016-00473016-004-01, 73016-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PROPANEDIOL5965N8W85TIACT
DIMETHICONE92RU3N3Y1OIACT
BEMOTRIZINOLPWZ1720CBHIACT
NIACINAMIDE25X51I8RD4IACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)P0TX083987IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
C14-22 ALCOHOLSB1K89384RJIACT
TREHALOSEB8WCK70T7IIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
DOCOSANOL9G1OE216XYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARIC ACID4ELV7Z65APIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
XANTHAN GUMTTV12P4NEEIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ADENOSINEK72T3FS567IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERRIC OXIDE RED1K09F3G675IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ZINC OXIDESOI2LOH54ZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CAMELLIA JAPONICA SEED OILU37N0S910TIACT
D&C RED NO. 339DBA0SBB0LIACT

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
85a9522e-a700-bd04-e053-2a91aa0a61f361fabd61-c3f8-4045-a83d-3192bb2cb41a2019-04-03WarningsExact identifier
spl id: 85a9522e-a700-bd04-e053-2a91aa0a61f3
spl set id: 61fabd61-c3f8-4045-a83d-3192bb2cb41a

Reported adverse events (FAERS/openFDA)#

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