VSHELL SUNSCREEN- sunscreen cream

VSHELL sunscreen by

Drug Labeling and Warnings

VSHELL sunscreen by is a Otc medication manufactured, distributed, or labeled by Guangdong Miaolian Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN PACKAGE

uses

1.Active Ingredient: Octocrylene 4%
Ethylhexyl salicylate 4%
Diethylhexyl butamido triazone 2%
Ethylhexyl triazone 2%
Tocopheryl acetate 1%
Titanium dioxide/silica/triethoxycaprylylsilane 2%
2.Purpose: Helps prevent sunburn
3.Use: 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.
4.Warnings: For external use only
5.Do not use: Do not use on damaged or broken skin.
6.When Using : When using this product
keep out of eyes. Rinse with wate to remove
Stop use and ask doctor if rash occurs.
7.Stop Use : Stop use and ask a doctor if rash occurs
8.Ask Doctor: Children under 6 months of age: Ask a doctor.
9.Keep Oot Of Reach Of Children
: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
10.Directions: Apply liberally 15minutes before sun exposure.
Reapply after 40 minutes of swimming or sweating immediately after towel drying.
Reapply at least every 2hours.
11.Other information: Protect the product in this container from excessive heat and direct sun.
Validity: 3 years
12.Inactive ingredients: Diisopropyl sebacate, diethylaminohydroxybenzoyl hexyl benzoate, butyl methoxydibenzoylmethane, isononyl isononanoate, diisopropyl adipate, bis-ethylhexyloxyphenol methoxyphenyl triazine , Polyhydroxystearic acid, Cetyl Dimethicone/Hexadecene/Dimethicone, Dimethicone, Cyclopentasiloxane, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-10 Stearate, Polyglyceryl-6 Distearate, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer/Polysorbate-60/Sorbitan Isostearate, Xanthan Gum, Methylpropanediol, Glycerin, Water, Potassium Cetyl Phosphate, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol/Decyl Glucoside/Propylene Glycol/Xanthan Gum/Water, Dipropylene Glycol/1,2-Hexanediol/Caprylyl Glycol/Ethylhexylglycerin
13.Questions: Toll-free number 001 (206)852-4528

INGREDIENTS AND APPEARANCE

VSHELL SUNSCREEN 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84507-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISCOTRIZINOL (UNII: 2UTZ0QC864) (ISCOTRIZINOL - UNII:2UTZ0QC864)	ISCOTRIZINOL	2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 mL
TOCOTRIENOLS (UNII: KP2MW85SSQ) (TOCOTRIENOLS - UNII:KP2MW85SSQ)	TOCOTRIENOLS	1 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
BEMOTRIZINOL (UNII: PWZ1720CBH)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
AVOBENZONE (UNII: G63QQF2NOX)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
1-HEXADECENE (UNII: 97T015M2UX)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BISOCTRIZOLE (UNII: 8NT850T0YS)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84507-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		07/13/2024

Labeler - Guangdong Miaolian Cosmetics Co., Ltd. (707598469)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Miaolian Cosmetics Co., Ltd.		707598469	manufacture(84507-001)