ZEALIOS SPORT PERFORMANCE ULTRALIGHT SPF 50 SUNSCREEN- homosalate, octocrylene, octisalate, and avobenzone cream

Zealios Sport Performance Ultralight SPF 50 Sunscreen by

Drug Labeling and Warnings

Zealios Sport Performance Ultralight SPF 50 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

Active Ingredients:			Purpose
Homosalate	15%		Sunscreen
Octocrylene	10%		Sunscreen
Octyl Salicylate	5%		Sunscreen
Avobenzone	3%		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, Butyloctyl Salicylate, Coconut Alkanes, Coco-Caprylate/Caprate, Hydrogenated Methyl Abietate, Organic Aloe Barbadensis Leaf Juice, Glycerin, Hydrolyzed Jojoba Esters, Glyceryl Stearate, Glyceryl Stearate Citrate, Sodium Stearoyl Glutamate, Rosa Canina (Rosehip) Fruit Oil, Daucus Carota Sativa (Carrot) Seed Oil, Rice Starch, Polyglyceryl-4 Isostearate, Lysolecithin, Sclerotium Gum, Xanthan Gum, Pullulan, Phenoxyethanol, Biosaccharide Gum-1, Ethylhexylglycerin, Niacinamide, Tocopherol

Other Info

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

zealios ®

SPORT PERFORMANCE
SUNSCREEN
50

ULTRALIGHT

+ Hydration

Broad Spectrum SPF 50
Water Resistant (80 min.)
Fragrance Free

32 fl oz (946 ml)

INGREDIENTS AND APPEARANCE

ZEALIOS SPORT PERFORMANCE ULTRALIGHT SPF 50 SUNSCREEN 
homosalate, octocrylene, octisalate, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83326-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	13200 mg
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	8800 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4400 mg
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2640 mg

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Coconut Alkanes (UNII: 1E5KJY107T)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
Hydrogenated Methyl Abietate (UNII: A23O709X8O)
Glycerin (UNII: PDC6A3C0OX)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CARROT SEED OIL (UNII: 595AO13F11)
STARCH, RICE (UNII: 4DGK8B7I3S)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
Xanthan Gum (UNII: TTV12P4NEE)
Pullulan (UNII: 8ZQ0AYU1TT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
Biosaccharide Gum-1 (UNII: BB4PU4V09H)
Ethylhexylglycerin (UNII: 147D247K3P)
Niacinamide (UNII: 25X51I8RD4)
Tocopherol (UNII: R0ZB2556P8)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83326-003-03	1 in 1 TUBE; Type 0: Not a Combination Product	02/20/2025
2	NDC: 83326-003-32	1 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/20/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Cosmetics		189788201	MANUFACTURE(83326-003)