INTROSTEM VITISCELL FACIAL SHIELD- octinoxate, homosalate, octisalate, oxybenzone and avobenzone cream

Introstem Vitiscell Facial Shield by

Drug Labeling and Warnings

Introstem Vitiscell Facial Shield by is a Otc medication manufactured, distributed, or labeled by Lionesse USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.40%
Homosalate 6.20%
Octisalate 5.00%
Oxybenzone 3.10%
Avobenzone 1.50%

Purpose

Sunscreen

Uses

• ▪ Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Stop using this product

and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

If accidental ingestion, call the Poison Control Center right away.

Directions

• ▪ After cleansing, apply liberally and evenly 15 minutes before sun exposure.
  Smooth over face and neck and chest daily for optimal results.
• ▪ Reapply at least every two (2) hours.
• ▪ Use water resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• ▪ limit time in the sun, especially from 10 a.m.-2 p.m.
• ▪ wear long-sleeved shirts, pants, hats and sunglasses

For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Vitis Vinifera (Grape) Fruit Cell Extract, Disodium EDTA.

Package/Label Principal Display Panel

INTROSTEM®

VITISCELL FACIAL SHIELD CREAM
VitisCell Crème Solaire Visage SPF 30
BROAD SPECTRUM SPF 30

infused with grape stem cell extract

60g ǀ 2.1oz

www.introstem.com
20255 Corisco St.
Chatsworth, CA 91311

Label

INGREDIENTS AND APPEARANCE

INTROSTEM VITISCELL FACIAL SHIELD 
octinoxate, homosalate, octisalate, oxybenzone and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72104-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.1 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
WINE GRAPE (UNII: 3GOV20705G)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72104-082-72	1 in 1 CARTON	10/01/2023
1		60 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/01/2023

Labeler - Lionesse USA, Inc. (079661431)