ZEALIOS SUN BARRIER SPF 45- zinc oxide, octinoxate, and octisalate cream

Zealios Sun Barrier SPF 45 by

Drug Labeling and Warnings

Zealios Sun Barrier SPF 45 by is a Otc medication manufactured, distributed, or labeled by Personal Best Products Inc. dba Zealios, Swiss American CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:	Purpose
Zinc Oxide 8.00%	Sunscreen
Octinoxate 7.50%	Sunscreen
Octisalate 3.00%	Sunscreen

Uses

• - 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.
• - Stop use and ask a doctor if rash occurs.
• - When using this product keep out of eyes. Rinse with water to remove.

• - Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

• - Apply liberally 15 minutes before sun exposure.
• - Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
  • Children under 6 months: Ask a doctor.

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 am – 2 pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Hexyl Isononanoate, Iodopropynyl Butylcarbarnate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethoxycaprylysilane

Other Info

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 88 ml Tube Label

SPORT PERFORMANCE
SUN BARRIER

SPF 45
BROAD SPECTRUM
8% Micronized Zinc Oxide

DRIES
CLEAR

Water Restant (80 min.)
Oil & Fragrance Free
Non-Greasy Sunscreen

3 fl oz (88 ml)

INGREDIENTS AND APPEARANCE

ZEALIOS SUN BARRIER SPF 45 
zinc oxide, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83326-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83326-001-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2015
2	NDC: 83326-001-02	88 mL in 1 TUBE; Type 0: Not a Combination Product	07/08/2015
3	NDC: 83326-001-03	10 mL in 1 PACKET; Type 0: Not a Combination Product	07/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	07/08/2012

Labeler - Personal Best Products Inc. dba Zealios (075619252)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO		080170933	MANUFACTURE(83326-001)