AVA ISA SUN SERUM- zinc oxide liquid

Ava Isa Sun Serum by

Drug Labeling and Warnings

Ava Isa Sun Serum by is a Otc medication manufactured, distributed, or labeled by Cyberderm Laboratories inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 25%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only.

Do not use on broken skin.

When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children over 6 months of age:

• Apply liberally to face and body 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• 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

STORAGE AND HANDLING

Other information

• Protect this product from excessive heat and direct sun.
• May stain some fabrics

INACTIVE INGREDIENT

Inactive ingredients

Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Polylactic Acid, Coconut Alkanes, Coco-Caprylate/Caprate, Carthamus Tinctorius Oleasomes, Aqua, Cellulose, Bis (Cyano Butylacetate) Anthracenediylidene (Micah), Sorbitan Oleate

QUESTIONS

Questions?
718-481-2628 Monday-Friday, 9 am - 5 pm

SPL UNCLASSIFIED SECTION

For more information, please go to thesunscreencompany.com

Distributed by

Cyberderm Laboratories Inc.

660-1600 Carling Avenue

Ottawa, ON K1Z 1G3

Canada

PRINCIPAL DISPLAY PANEL

AVA ISA
Sun-e-Serum Drops
Broad Spectrum SPF 35
Transparent Sunscreen Lotion
UVA/UVB Protection
Made with 25% Zinc Oxide and Micah®
30 ml (1 fl oz)

INGREDIENTS AND APPEARANCE

AVA ISA SUN SERUM 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYLACTIDE (UNII: 459TN2L5F5)
WATER (UNII: 059QF0KO0R)
BUTYL CYANOACETATE (UNII: F9H6L20VOH)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-007-30	1 in 1 CARTON	03/11/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/11/2020

Labeler - Cyberderm Laboratories inc. (242524267)