SKINTX UV PRO BROAD SPECTRUM SPF45- zinc oxide, octocrylene, octinoxate, octisalate lotion 
Vivier Pharma Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SkinTx UV Pro Broad Spectrum SPF45

DRUG FACTS

ACTIVE INGREDIENTS

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

PURPOSE

Sunscreen

USES

■ Helps prevent sunburn and provides a sun protection factor of 45.
■ Ideal for daily use; can be applied under makeup.

For external use only

■ The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

When using this product

■ Keep out of eyes. Rinse with water to remove.
■ Do not use on damaged or broken skin.

Stop use and ask a doctor if

■ Rash or irritation develops and lasts.

Keep out of reach of children.

■ If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

■ Apply daily to face, neck and chest.
■ Apply liberally and evenly 15 minutes before sun exposure.
■ For use on children less than 6 months of age, consult a healthcare practitioner.
■ Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
■ Use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients

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

Questions?

450 455 9779                                  1 877 484 8437

Store at room temperature (15-30°C / 59-86°F).

Product Labels

BottleCarton

SKINTX UV PRO BROAD SPECTRUM SPF45 
zinc oxide, octocrylene, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2945
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION99 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67226-2945-91 in 1 CARTON05/14/201507/01/2017
190 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:67226-2945-41 in 1 CARTON05/14/201507/01/2017
24 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/14/201507/01/2017
Labeler - Vivier Pharma Inc. (250996550)

Revised: 3/2018
 
Vivier Pharma Inc.