FDA.reportPublic FDA data

Ava Isa Sun Serum Drops SPF 35

Manufacturer
Cyberderm Laboratories inc.
Effective date
2026-01-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:53:00

Label at a glance#

ProductAva Isa Sun Serum
Active ingredientZINC OXIDE
Label structure11 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 25%

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 broken skin.

OTC - WHEN USING SECTION

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

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, call a poison control centre or get medical help right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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)

AvaIsaSunESerumAvaIsaSunESerum

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71644-007-302023-11-27C16284748780-10191ceaa-6d7c-198a-e063-dbdaa90aec3eAva Isa Sun Serum Drops SPF 35
71644-007-302023-07-28C16284748780-10191ceaa-6d7c-198a-e063-dbdaa90aec3eAva Isa Sun Serum Drops SPF 35

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-00771644-007-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYLACTIDE459TN2L5F5IACT
WATER059QF0KO0RIACT
BUTYL CYANOACETATEF9H6L20VOHIACT
POWDERED CELLULOSESMD1X3XO9MIACT
COCONUT ALKANES1E5KJY107TIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
ZINC OXIDESOI2LOH54ZACTIM
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT

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
4a8df6e4-245f-2217-e063-6294a90a6d37a09623f3-40f4-e3fe-e053-2a95a90ad5392026-02-11WarningsExact identifier
spl set id: a09623f3-40f4-e3fe-e053-2a95a90ad539

Reported adverse events (FAERS/openFDA)#

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