SKINTX UV PRO BROAD SPECTRUM SPF30- zinc oxide, octinoxate, octisalate lotion

SkinTx UV Pro Broad Spectrum SPF30 by

Drug Labeling and Warnings

SkinTx UV Pro Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Dermolab Pharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

9.9% Zinc Oxide
8.0% Octocrylene
7.5% Ethylhexyl Methoxycinnamate
5.0% Ethylhexyl Salicylate

PURPOSE

Sunscreen

Inactive Ingredients

Behenyl Alcohol, Butylparaben, Butyrospermum Parkii, C12-15 Alkyl Benzoate, Ceteareth-20, Cetearyl Alcohol, Cyclopentasiloxane, Cyclotetrasiloxane, Diethylhexyl 2,6-Naphtalate, Ethylparaben, Methylparaben, Phenoxyethanol, Phenyl Trimethicone, Propylparaben, Silica, Sodium Stearoyl Glutamate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Water/Eau.

Product Labels

INGREDIENTS AND APPEARANCE

SKINTX UV PRO BROAD SPECTRUM SPF30 
zinc oxide, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42521-2930
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	99 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42521-2930-9	1 in 1 CARTON	05/14/2015
1		90 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 42521-2930-4	1 in 1 CARTON	05/14/2015
2		4 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 not final	part352	05/14/2015

Labeler - Dermolab Pharma Ltd (245414743)

Establishment
Name	Address	ID/FEI	Business Operations
Dermolab Pharma Ltd		245414743	manufacture(42521-2930)