SKINUVA SCAR PLUS- zinc oxide cream

Skinuva Scar plus by

Drug Labeling and Warnings

Skinuva Scar plus by is a Otc medication manufactured, distributed, or labeled by MD Medical Designs, Inc., Dermazone LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose*
* Data on file
Zinc Oxide 10%	Sunscreen
Dosage Form	Cream

Uses

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

Warnings

For external use only.

Do not use on damaged/broken skin or open wounds.

When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label.

Stop use and ask a doctor if rash or irritation occurs.

Keep out of reach of children.

Directions

Make sure the affected area is clean and dry. Apply a thin film over the affected area twice a day, morning and night. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. See insert for detailed instructions.

Other information

Do not use if inner seal is broken. Store at room temperature. Avoid excessive heat.

Inactive ingredients

Water/Aqua, Dimethicone, Dimethiconol, Cyclopentasiloxane, Dimethicone Crosspolymer, Butylene Glycol, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Tetrahexyldecyl Ascorbate, Centella Asiatica Extract, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, sh-Polypeptide-1, Tocopherol, sh-Polypeptide-6, sh-Polypeptide-5

SPL UNCLASSIFIED SECTION

Dist. by: MD Medical Designs, Inc.
Beverly Hills, CA 90210

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC: 82350-352-30

SKINUVA®
scar+

BROAD SPECTRUM SPF 30

Scar photoaging defense cream using
highly selective growth factors with
Zinc Oxide mineral sunscreen

Developed and tested
by physicians

30 mL / 1 fl. oz e

INGREDIENTS AND APPEARANCE

SKINUVA SCAR PLUS 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82350-352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
INTERLEUKIN-10 (UNII: 9SC4O216V9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82350-352-15	1 in 1 CARTON	06/30/2022
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 82350-352-30	1 in 1 CARTON	06/30/2022
2		30 mL in 1 BOTTLE; 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	06/30/2022

Labeler - MD Medical Designs, Inc. (094586004)

Establishment
Name	Address	ID/FEI	Business Operations
Dermazone LLC		131639839	MANUFACTURE(82350-352) , PACK(82350-352)