Label: ZEALIOS SUN BARRIER SPF 45- zinc oxide, octinoxate, and octisalate cream
- NDC Code(s): 83326-001-01, 83326-001-02, 83326-001-03
- Packager: Personal Best Products Inc. dba Zealios
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
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
- PRINCIPAL DISPLAY PANEL - 88 ml Tube Label
-
INGREDIENTS AND APPEARANCE
ZEALIOS SUN BARRIER SPF 45
zinc oxide, octinoxate, and octisalate creamProduct 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)
