FDA.reportPublic FDA data

Ava Isa

Manufacturer
Cyberderm Laboratories Inc.
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:06:05

Label at a glance#

ProductAva Isa Aurora Rose SPF 45
Active ingredientZINC OXIDE
Label structure15 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc oxide* 15%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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)

Ava Isa Aurora Rose 50 mLAva Isa Aurora Rose 50 mL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-00171644-001-50, 71644-001-80

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
ISOSTEARIC ACIDX33R8U0062IACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
POLYLACTIDE459TN2L5F5IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPANEDIOL5965N8W85TIACT
UNDECANEJV0QT00NUEIACT
TRIDECANEA3LZF0L939IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CERIC OXIDE619G5K328YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
XANTHAN GUMTTV12P4NEEIACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b48e4c49-4b85-79e2-e053-2995a90a3393626c47bc-bbc0-d84f-e053-2a91aa0af9562020-11-20WarningsExact identifier
spl id: b48e4c49-4b85-79e2-e053-2995a90a3393
spl set id: 626c47bc-bbc0-d84f-e053-2a91aa0af956

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.