FDA.reportPublic FDA data

Ava Isa Sun Lip Sun Whip

Product NDC
71644-010
11-digit product format
716440010
Labeler code
71644
Product ID
71644-010_48326f62-4953-fcd3-e063-6294a90a9fef
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cyberderm Laboratories inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-18
Substance
ZINC OXIDE
Active strength
20 g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Ava Isa Sun Lip Sun Whip
Brand name suffix
Strawberry Zinnia
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a888396f-489f-7e7c-e053-2995a90aee5bAvailable on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-010AVA ISA SUN LIP SUN WHIP STRAWBERRY ZINNIA (ZINC OXIDE) CREAM [CYBERDERM LABORATORIES INC.]3Current NDC, Legacy NDC, 2 package rows20231128_a888396f-489f-7e7c-e053-2995a90aee5b.zip

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 41 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light MediumZINC OXIDEZO Skin Health, Inc.4fabe9d0-27fe-230f-e063-6294a90a9ac02026-04-17WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-TanZINC OXIDEZO Skin Health, Inc.4fac82b7-d685-2a0d-e063-6394a90aa7952026-04-17WarningsExact identifier
application number: M020
SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4fae649d-f60e-0275-e063-6294a90a1ea52026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHTYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cfaea-b71f-2956-e063-6294a90a4f202026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUMYOUR NAME MINERAL SHEER TINTPML NYC, LLC316d1515-6092-a7d6-e063-6394a90ab8b22026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e70-6ec3-5711-e063-6394a90a38792026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC0e241343-db63-3f1c-e063-6394a90ab5382026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC316df5fe-0574-d59f-e063-6294a90af8b92026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316c5d69-46f4-7677-e063-6294a90a610f2026-04-17WarningsExact identifier
application number: M020
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20PML NYC, LLC316d905f-232c-d8a2-e063-6394a90adbc92026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NPML NYC, LLC316ea01b-4bff-55be-e063-6394a90add942026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NPML NYC, LLC316e97bc-4b96-ba6e-e063-6294a90a76482026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c781d7-9d48-892f-e053-2a95a90aca862026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c757b4-6c92-18f0-e053-2a95a90a246d2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c76a82-dc87-35e7-e053-2995a90ae3102026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7ac71-3f38-52b2-e053-2a95a90ab54e2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7b929-7492-f072-e053-2995a90a1ca32026-04-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71644-010-10716440010101 TUBE in 1 CARTON (71644-010-10) / 10 mL in 1 TUBE1 tube2020-06-190000-00-00NoNoCurrent