AVA ISA AURORA ROSE SPF 45- 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc oxide* 15%

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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• 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
• Children under 6 months of age: ask a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients water/eau, coco-caprylate/caprate*, polyglyceryl-3 polyricinoleate*, isostearic acid*, polylactic acid*, caprylic/capric triglyceride*, propanediol*, undecane*, tridecane*, cetearyl olivate*, sorbitan olivate*, polyglyceryl-3 dicitrate/stearate*, titanium dioxide, stearic acid, alumina, cerium dioxide, silica, aluminum hydroxide, polyhydroxystearic acid, caprylhydroxamic acid, caprylyl glycol, glycerin*, polygonum aviculare extract, xanthan gum. May contain iron oxide (CI 77491), titanium dioxide (CI No. 77891), mica

* denotes ingredients that are Ecocert Certified Organic

QUESTIONS

Questions or comments?

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

SPL UNCLASSIFIED SECTION

*Denotes ingredients that are Ecocert® certified organic.

Distributed by:

Cyberderm Laboratories INc.

650-1600 Carling Avenue

Ottawa, ON K1Z 1G3 Canada

Made in Canada

PRINCIPAL DISPLAY PANEL

AVA ISA

Aurora Rose Ultra Matte SPF 45 Sunscreen

with Certified Organic Bio UVA Ultra

Made with 15% Zinc Oxide

Transparent Sunscreen Lotion

UVA/UVB Broad Spectrum SPF 45

Helps Prevent Sunburn

50 mL (1.7 fl oz)

INGREDIENTS AND APPEARANCE

AVA ISA  AURORA ROSE SPF 45
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARIC ACID (UNII: X33R8U0062)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYLACTIDE (UNII: 459TN2L5F5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
UNDECANE (UNII: JV0QT00NUE)
TRIDECANE (UNII: A3LZF0L939)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CERIC OXIDE (UNII: 619G5K328Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-001-50	1 in 1 CARTON	03/30/2018
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71644-001-80	1 in 1 CARTON	03/30/2018
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 final	part352	03/30/2018

Labeler - Cyberderm Laboratories Inc. (242524267)