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 203 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a093b-cc9c-26fc-e063-6394a90a20282025-07-22WarningsExact identifier
application number: M020
Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a87d6-ef86-60c2-e063-6394a90a07062025-07-22WarningsExact identifier
application number: M020
Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8b773c-f456-836a-e063-6294a90a0d462025-07-22WarningsExact identifier
application number: M020
Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bc90d-350f-98c8-e063-6294a90abd9c2025-07-22WarningsExact identifier
application number: M020
Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bd5d8-1c4c-0407-e063-6394a90a138f2025-07-22WarningsExact identifier
application number: M020
CLEAR GLOW RADIANT SUN SERUM SPF50AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN)NAKED SUNDAYS PTY LTDd748e291-3a29-663c-e053-2995a90a8d922025-07-22WarningsExact identifier
application number: M020
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
application number: M020
PREDIRE PARIS skin shield protector mineral defense creamPREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAMGuangzhou Fantesy Biotechnology Co.,Ltd3a7c1345-532f-b38f-e063-6394a90a52452025-07-21WarningsExact identifier
application number: M020
Medicated Peppermint Lip BalmDIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATEBlistex Inc5d48a6fa-ddce-47c3-9b09-1f3abb6950172025-07-18WarningsExact identifier
application number: M020
ICD Moisture Layer SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEICD Moisture Layer Sunscreen3a2a74f2-9fed-808f-e063-6294a90a410c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 2ZINC OXIDEG2G Ventures, PBC3a35c95b-10eb-689f-e063-6394a90ae1d42025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 3ZINC OXIDEG2G Ventures, PBC3a35bbb2-a1eb-346b-e063-6294a90a90782025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 4ZINC OXIDEG2G Ventures, PBC3a35f23b-3732-db3c-e063-6294a90ae00c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5ZINC OXIDEG2G Ventures, PBC3a35fd79-f4d3-5ccf-e063-6294a90a97982025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6ZINC OXIDEG2G Ventures, PBC3a360053-5863-95fe-e063-6394a90a45c52025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8ZINC OXIDEG2G Ventures, PBC3a362e05-3a1e-8059-e063-6294a90ad5252025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7ZINC OXIDEG2G Ventures, PBC3a3621c2-709a-82fd-e063-6294a90a7a7e2025-07-18WarningsExact identifier
application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc3a39ac31-85c9-5e04-e063-6394a90aa5372025-07-18WarningsExact identifier
application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3afeda-f235-eac2-e063-6294a90a5a932025-07-18WarningsExact identifier
application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3b5f56-aa36-01c7-e063-6294a90a6d622025-07-18WarningsExact 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