PERRICONE MD COLD PLASMA PLUS DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF 35- zinc oxide, titanium dioxide cream

Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35 by

Drug Labeling and Warnings

Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35 by is a Otc medication manufactured, distributed, or labeled by THG Beauty USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Zinc Oxide 5.10%
• Titanium Dioxide 4.17%

PURPOSE

• Sunscreen

INDICATIONS & USAGE

• Helps prevent sunburn.
• 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.

WARNINGS

• For external use only.

DO NOT USE

• on damaged or broken skin

WHEN USING

• keep out of eyes. Rinse with water to remove.

STOP USE

• Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

• If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

For Sunscreen Use:

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Not for use on children.
• 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

OTHER SAFETY INFORMATION

• Protect the product in this contaner from excessive heat and direct sun.

INACTIVE INGREDIENT

Water/Aqua/Eau, Glycerin, Dimethicone, Isononyl Isononanoate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Niacinamide, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Lecithin, Phenoxyethanol, Polysorbate 20, Stearic Acid, Tetrahexyldecyl Ascorbate, Polysilicone-11, Butylene Glycol, Aluminum Hydroxide, Isohexadecane, Phosphatidylcholine, Bisabolol, Citric Acid, Polyhydroxystearic Acid, Isopropyl Titanium Triisostearate, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Copper Tripeptide-1, Mica, Carbomer, Potassium Sorbate, Sodium Hyaluronate, Sodium Lactate, Helianthus Annuus (Sunflower) Seed Oil, Sodium Benzoate, Acetyl Hexapeptide-8, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ascorbyl Palmitate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Triethoxycaprylylsilane, Blue 1 Lake (CI 42090), Titanium Dioxide (CI 77891)

QUESTIONS

• 1-888-823-7837

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERRICONE MD COLD PLASMA PLUS DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF 35 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84448-519
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.17 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SODIUM LACTATE (UNII: TU7HW0W0QT)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BISABOLOL (UNII: 24WE03BX2T)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BLUE 1 LAKE (UNII: J9EQA3S2JM)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SOYBEAN PHOSPHATIDYLCHOLINE (UNII: 1T6N4D9YV6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
GLYCERIN (UNII: PDC6A3C0OX)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SILICA (UNII: ETJ7Z6XBU4)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
COPPER TRIPEPTIDE-1 (UNII: 6BJQ43T1I9)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MICA (UNII: V8A1AW0880)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
ROSEMARY (UNII: IJ67X351P9)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER (UNII: 0A5MM307FC)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID (UNII: 2968PHW8QP)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84448-519-30	1 in 1 CARTON	09/26/2023
1		30 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 84448-519-59	1 in 1 CARTON	09/26/2023
2		59 mL 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	M020	09/26/2023

Labeler - THG Beauty USA LLC (015792160)