FDA.reportPublic FDA data

ORLASKIN HYDRATING SUNSCREEN

Manufacturer
Guangzhou Fantesy Biotechnology Co.,Ltd
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:08

Label at a glance#

ProductORLASKIN HYDRATING SUNSCREEN
Active ingredientOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures ( see directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.

Dosage and administration

Shake the spray bottle well before use. Hold the spray bottle at an appropriate distance from the face and neck . Spray evenly onto the entire face and neck area. Avoid direct contact with eves . In case of eye contact , rinse immediately with water. For continued sun protection , reapply every 2 hours

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Avobenzone 3%

OTC - PURPOSE SECTION

sunscreen

Uses

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 ageing caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes , wear protective clothing , hats and eyewear when exposed to the sun . Avoid prolonged exposure in the sun.

Keep out of reach of children.

Do not use on damaged or brokenskin.

Store in a cool , dry place and avoiddirect sunlight.

If using with other sun protection products , consult with a doctor before use.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Shake the spray bottle well before use.

Hold the spray bottle at an appropriate distance from the face and neck . Spray evenly onto the entire face and neck area.

Avoid direct contact with eves . In case of eye contact , rinse immediately with water.

For continued sun protection , reapply every 2 hours

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Auqa , Methacrylate Copolymer , Alcohol Denat , Bisabolol , Hvaluronic Acid, D-alpha-tocopheryl acetate , Terminalia Ferdinandiana , Butyloctyl Salicylate, Sebacic Acid Copolymer , Dicaprylyl Ether , Diheptyl Succinate , Diisooctyl Succinate , Ethyl Ferulat , Isononyl sononanoate , Pelargonium Graveolens Flower Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83447-003-0183447-003-01

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136937684121421GTIN-13: 6937684121421
EAN-13: 6937684121421
GTIN storage (14 digits): 06937684121421		83447-003-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-003-01ORLASKIN HYDRATING SUNSCREEN100 mL in 1 BOXSPRAY1003

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83447-00383447-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
HYALURONIC ACIDS270N0TRQYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
KAKADU PLUM0ZQ1D2FDLIIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)P2OM2Q86BIIACT
ALCOHOL3K9958V90MIACT
LEVOMENOL24WE03BX2TIACT
DICAPRYLYL ETHER77JZM5516ZIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
ETHYL FERULATE5B8915UELWIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
DOCUSATE SODIUMF05Q2T2JA0IACT

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
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
ndc (package): 83447-003-01
ndc (product): 83447-003
ndc11 (package): 83447000301
spl id: 479ede48-5b2e-5407-e063-6394a90aab53
spl set id: 0808b0cd-2cfb-8554-e063-6294a90ad6c4

Reported adverse events (FAERS/openFDA)#

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