ZEALIOS MINERAL SPF 30 SUNSCREEN- zinc oxide cream

Zealios Mineral SPF 30 Sunscreen by

Drug Labeling and Warnings

Zealios Mineral SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Personal Best Products Inc. dba Zealios, Sun Deep Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

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 as soon as possible.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and 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 limiting time in the sun, especially from 10 am – 2 pm and wearing long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Cetyl Dimethicone, Hexyl Laurate, Glycerin, Hydrogenated Methyl Abietate, Dimethicone, Brassica Oleracea Acephala (Kale) Leaf Extract, Moringa Oleifera Seed Oil, Caprylhydroxamic Acid, Glyceryl Caprylate, Glycerin, Magnesium Sulfate, Hydrogenated Castor Oil, Sorbitan Sesquioleate

Other Info

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

zealios®

SPORT PERFORMANCE
SUNSCREEN
30

MINERAL

Reef Safe

Broad Spectrum SPF 30
20% Non-Nano Zinc Oxide
Water Resistant (80 min.)
Fragrance Free

32 fl oz (946 ml)

INGREDIENTS AND APPEARANCE

ZEALIOS MINERAL SPF 30 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83326-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17600 mg

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Glycerin (UNII: PDC6A3C0OX)
Hydrogenated Methyl Abietate (UNII: A23O709X8O)
Dimethicone, Unspecified (UNII: 92RU3N3Y1O)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Kale (UNII: 0Y3L4J38H1)
Moringa Oleifera Seed Oil (UNII: REM6A5QMC0)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83326-004-03	1 in 1 TUBE; Type 0: Not a Combination Product	06/01/2024
2	NDC: 83326-004-32	1 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Cosmetics		189788201	MANUFACTURE(83326-004)