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 296 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATESICOS ET CIE3b49a970-653b-4256-b2d3-4e065db638492024-06-24WarningsExact identifier
application number: M020
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATEL'Oreal USA Products Inc.1b851e19-add0-437b-86e4-e88a10a1e7742024-06-24WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
application number: M020
Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1b6bf419-554c-86a7-e063-6294a90a5a7e2024-06-21WarningsExact identifier
application number: M020
OS-01 Body SPF 30ZINC OXIDEAllure Labs1b582f4e-553f-a511-e063-6294a90af3c02024-06-20WarningsExact identifier
application number: M020
Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50ZINC OXIDEThe Seaweed Bath Co.65c9c131-2545-4d88-aa9a-85197b654d742024-06-19WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
application number: M020
EB-5 Super Hydrating Anti-Aging SPF-50OCTOCRYLENE, ZINC OXIDE, OCTISALATELIFE O, INC.b9521112-d119-4d48-8504-4e46b434f76f2024-06-17WarningsExact identifier
application number: M020
Burts Bees SPF 30 Untinted Lip Balm Beaches and CreamBURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAMAutumn Harp1ac89261-eeae-567c-e063-6294a90ad45f2024-06-13WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
application number: M020
Mara Clear Skin Mineral Milk Acne TreatmentSALICYLIC ACIDMara Beauty LLC3823024e-81b4-4e29-af76-82231e09407c2024-06-13WarningsExact identifier
application number: M020
BOB KIDS SPF 30 Zinc onlyZINC OXIDESPF Ventures, LLC1aae0291-f16f-7840-e063-6394a90a34432024-06-12WarningsExact identifier
application number: M020
Glossier Invisible Shield SPF 50GLOSSIER INVISIBLE SHIELD SPF 50Autumn Harp1ab39eae-06e9-0e4c-e063-6394a90ad8aa2024-06-12WarningsExact identifier
application number: M020
Thinksport SPF 50ZINC OXIDEthinkOperations,LLC2e83e382-8eb0-40f2-bdca-2db5e184661e2024-06-10WarningsExact identifier
application number: M020
Thinkkids SPF 50ZINC OXIDEthinkOperations,LLC09f9d9bb-c08b-401c-bbf1-640f1c8ec6782024-06-07WarningsExact identifier
application number: M020
NAELI Day Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEALLI LLCf2cebdc7-c96e-46cf-9b5c-b4965ddd2aec2024-06-06WarningsExact identifier
application number: M020
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
application number: M020
Thinkbaby SPF 50ZINC OXIDEthinkOperations,LLCf2788a1a-daf6-4b7d-8333-585a380ebe572024-06-05WarningsExact identifier
application number: M020
RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTERZINC OXIDERms organics LLC1a11c884-d6ba-d77f-e063-6394a90a5bd22024-06-04WarningsExact identifier
application number: M020
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact 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