ORLASKIN HYDRATING SUNSCREEN spray

ORLASKIN HYDRATING SUNSCREEN by

Drug Labeling and Warnings

ORLASKIN HYDRATING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Guangzhou Fantesy Biotechnology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 10%

Octocrylene 8%

Octilsalate 5%

Avobenzone 3%

PURPOSE

sunscreen

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.

Warnings

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.

DO NOT USE

Do not use on damaged or broken skin

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

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

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORLASKIN HYDRATING SUNSCREEN 
orlaskin hydrating sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-003
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
WATER (UNII: 059QF0KO0R)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)
ALCOHOL (UNII: 3K9958V90M)
LEVOMENOL (UNII: 24WE03BX2T)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ETHYL FERULATE (UNII: 5B8915UELW)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-003-01	100 mL in 1 BOX; Type 0: Not a Combination Product	10/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/19/2023

Labeler - Guangzhou Fantesy Biotechnology Co.,Ltd (619047084)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-003)