ZEALIOS SUN BARRIER SPF 45- zinc oxide, octinoxate, and octisalate cream 
Personal Best Products Inc. dba Zealios

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Zealios Sun Barrier SPF 45

Drug Facts

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

Uses

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Helps prevent sunburn.
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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

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For external use only.
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Do not use on damaged or broken skin.
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Stop use and ask a doctor if rash occurs.
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When using this product keep out of eyes. Rinse with water to remove.

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

Directions

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Apply liberally 15 minutes before sun exposure.
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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:

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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)

PRINCIPAL DISPLAY PANEL - 88 ml Tube Label
ZEALIOS SUN BARRIER SPF 45 
zinc oxide, octinoxate, and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83326-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83326-001-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2015
2NDC:83326-001-0288 mL in 1 TUBE; Type 0: Not a Combination Product07/08/2015
3NDC:83326-001-0310 mL in 1 PACKET; Type 0: Not a Combination Product07/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02007/08/2012
Labeler - Personal Best Products Inc. dba Zealios (075619252)
Establishment
NameAddressID/FEIBusiness Operations
Swiss American CDMO080170933MANUFACTURE(83326-001)

Revised: 12/2023
Document Id: faa78cd9-fbb7-4c9a-a7fa-68a5a1bca20c
Set id: 2cbe11ce-3a4b-49a0-a7b9-7eca5e27f798
Version: 2
Effective Time: 20231227
 
Personal Best Products Inc. dba Zealios