AVA ISA SUN LIP SUN WHIP CLEAR SUNSHINE- zinc oxide cream

Ava Isa Sun Lip Sun Whip by

Drug Labeling and Warnings

Ava Isa Sun Lip Sun Whip 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* 20%

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 damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center 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 10am - 2pm
• Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: ask a doctor

STORAGE AND HANDLING

Other information

• Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable oil, Hydrogenated vegetable oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl laurate, Polyhydroxystearic Acid, Behenyl behenate, Polyglyceryl-10 stearate, Sodium stearoyl lactylate, Glyceryl Isostearate, d-alpha Tocopherol.

QUESTIONS

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

SPL UNCLASSIFIED SECTION

Distributed by

Cyberderm Laboratories, Inc.

650-1600 Carling Avenue

Ottawa, ON K1Z 1G3

Made in Canada

PRINCIPAL DISPLAY PANEL

AVA ISA
Sun Lip
Sun Whip®
Clear Sunshine
melt-on-contact all mineral lip balm
SPF 15 Broad Spectrum
UVA/UVB Protection
made with 20% zinc oxide
10 ml (.33 fl oz)
NPN 80097041

INGREDIENTS AND APPEARANCE

AVA ISA SUN LIP SUN WHIP  CLEAR SUNSHINE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CANDELILLA WAX (UNII: WL0328HX19)
LAURYL LAURATE (UNII: GPW77G0937)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED PALM OIL (UNII: 257THB963H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-009-10	1 in 1 CARTON	06/19/2020
1		10 mL in 1 TUBE; 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	06/18/2020

Labeler - Cyberderm Laboratories inc. (242524267)