ZEALIOS SPF LIPGUARD- octisalate and avobenzone gel

Zealios SPF LipGuard by

Drug Labeling and Warnings

Zealios SPF LipGuard 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:
Octyl Salicylate 5%	Sunscreen
Avobenzone 3%	Sunscreen

Uses

Helps prevent sunburn and chapped lips.

Warnings

For external use only. Stop use if skin rash occurs. When using keep out of eyes.

Keep out of reach of children. Protect this product from excessive heat.

Directions

Apply liberally 15 minutes before sun exposure and reapply every 2 hours or as necessary. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Caprylic/Capric Triglyceride, Petrolatum, Beeswax, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter) Fruit, Cocos Nucifera (Coconut Oil), Tocopheryl Acetate (Vitamin E), Simmondsia, Chinensis (Jojoba) Seed Oil.

PRINCIPAL DISPLAY PANEL - 7.39 ml Tube Label

zealios

SPORT PERFORMANCE
LIPGUARD

Natural

Ultra Lip Protection
& Hydration

SPF
28

Broad Spectrum
SPF 28 Sunscreen
Clear & Long-Lasting

0.25 fl oz (7.39 ml)

INGREDIENTS AND APPEARANCE

ZEALIOS SPF LIPGUARD 
octisalate and avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83326-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83326-002-01	7.39 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	06/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	06/21/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Cosmetics		189788201	MANUFACTURE(83326-002)