FDA.reportPublic FDA data

Ava Isa Sun Lip Sun Whip

Manufacturer
Cyberderm Laboratories inc.
Effective date
2026-01-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:34:00

Label at a glance#

ProductAva Isa Sun Lip Sun Whip Strawberry Zinnia
Active ingredientZINC OXIDE
Label structure11 sections

Storage and handling

Other information Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide* 20%

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 productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash 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

  • 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 SECTION

Other information

  • Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

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, Tocopherol. May contain CI 15850, Aluminum Hydroxide

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AVA ISA
Sun Lip
Sun Whip®
Strawberry Zinnia
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

AvaIsa LipBalm StrawberryZinniaAvaIsa LipBalm StrawberryZinnia

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
71644-010-102023-11-27C16284748780-10191ceaa-6db2-198a-e063-dbdaa90aec3eAva Isa Sun Whip Lip Balm Strawberry Zinnia
71644-010-102023-07-28C16284748780-10191ceaa-6db2-198a-e063-dbdaa90aec3eAva Isa Sun Whip Lip Balm Strawberry Zinnia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71644-010-10Ava Isa Sun Lip Sun WhipStrawberry Zinnia1 in 1 CARTONCREAM16
71644-010-10Ava Isa Sun Lip Sun WhipStrawberry Zinnia10 mL in 1 TUBECREAM106

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-01071644-010-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
D&C RED NO. 6481744AI4OIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SHEA BUTTERK49155WL9YIACT
MORELLA CERIFERA FRUIT WAXL41B20QT0MIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
CANDELILLA WAXWL0328HX19IACT
LAURYL LAURATEGPW77G0937IACT
BEHENYL BEHENATEK8NU647RJ0IACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
ZINC OXIDESOI2LOH54ZACTIM
CORN OIL8470G57WFMIACT
HYDROGENATED PALM OIL257THB963HIACT

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
Ava Isa Sun Lip Sun Whip Strawberry ZinniaZINC OXIDECyberderm Laboratories inc.a888396f-489f-7e7c-e053-2995a90aee5b2026-01-01WarningsExact identifier
ndc (package): 71644-010-10
ndc (product): 71644-010
ndc11 (package): 71644001010
spl id: 48326f62-4953-fcd3-e063-6294a90a9fef
spl set id: a888396f-489f-7e7c-e053-2995a90aee5b

Reported adverse events (FAERS/openFDA)#

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