AVA ISA EVERY MORNING- zinc oxide lotion

Ava Isa by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc oxide* 25%

PURPOSE

Purpose

Sun Protectant

INDICATIONS & USAGE

Uses

Helps prevent sunburn

WARNINGS

Warnings

For external use only

Do not use on broken skin

When using this product avoid contact with 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 Center 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 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING

Other information

• Protect from excessive heat and direct sun
• May stain some fabrics
• Apply to dry not damp skin to blend easily

INACTIVE INGREDIENT

Inactive ingredients

Aqua, coco-caprylate/caprate, polyclyceryl-3 polycrinoleate, isostearic acid, caprylic/capric triglyceride, propanediol, C-13-15 alkane, dimethicone/vinyl dimethicone crosspolymer, TMP lauryl dimethicone, caprylhydroxamic acid, 1,2 hexanediol, 7-dehydrocholesterol, sodium chloride, cerium oxide

QUESTIONS

Questions?

781-481-2628 Monday - Friday 9 am - 5 pm

SPL UNCLASSIFIED SECTION

Distributed by:

Cyberderm’s Laboratories Inc

89 Main Street East

Grimsby ON L3M 1N6 Canada

Made in Canada

PRINCIPAL DISPLAY PANEL

AVA ISA

Every Morning

SPF 30 Broad Spectrum

UVA/UVB Protection

made with 25% zinc oxide and

SPF 30 Transparent Sun Protection Lotion

50 mL (1.7 fl oz)

INGREDIENTS AND APPEARANCE

AVA ISA  EVERY MORNING
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-016
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
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
LAURYL TRISILOXANE (UNII: 5OHO78HI1D)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISOSTEARIC ACID (UNII: X33R8U0062)
CERIC OXIDE (UNII: 619G5K328Y)
C13-15 ALKANE (UNII: 114P5I43UJ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-016-50	1 in 1 CARTON	11/07/2023
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71644-016-80	1 in 1 CARTON	11/07/2023
2		80 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 Drug	M020	11/07/2023

Labeler - Cyberderm Laboratories Inc. (242524267)