FDA.reportPublic FDA data

Vivier Sheer SPF 45

Product NDC
67226-2852
11-digit product format
672262852
Labeler code
67226
Product ID
67226-2852_08bf32be-a1ca-0c37-e063-6294a90a5c9b
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Vivier Pharma, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-05
Substance
ZINC OXIDE; OCTOCRYLENE; OCTINOXATE; OCTISALATE
Active strength
99; 80; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Vivier Sheer SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE99 mg/mL
OCTOCRYLENE80 mg/mL
OCTINOXATE75 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c057138a-1111-4e7c-b94d-2ccd6bc3963cAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67226-2852-0Vivier Sheer SPF 451 in 1 CARTONLOTION13
67226-2852-0Vivier Sheer SPF 4590 mL in 1 TUBELOTION903
67226-2852-1Vivier Sheer SPF 451 in 1 CARTONLOTION13
67226-2852-1Vivier Sheer SPF 45250 mL in 1 TUBELOTION2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2852VIVIER SHEER SPF 45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA, INC.]3Current NDC, Legacy NDC, 4 package rows20231030_c057138a-1111-4e7c-b94d-2ccd6bc3963c.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 96 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc5dafd4-dfd4-d310-e053-2995a90a82a82025-12-31WarningsExact identifier
application number: M020
Coppertone EveryTone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Inc04c58384-fd82-f6d0-e063-6294a90a3ff12025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdort Inccc46b3a3-48f5-4593-e053-2995a90a87822025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport SPF 60 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb7304-789d-1f94-e063-6394a90a7e622025-12-31WarningsExact identifier
application number: M020
Coppertone Kids SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccbf9a785-f218-76fb-e053-2995a90a8e032025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60c2a38-ef92-0dff-e053-2995a90a47c42025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a5370-ec6f-42a7-e063-6394a90ac37c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd53e1253-f6a4-4f3d-e053-2a95a90a79ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Face SPF 60 Plus SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b36eb1-bffc-c31e-e063-6294a90a8eb32025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd47460a1-4768-ee44-e053-2a95a90adecf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd473e7ed-4a9f-76fe-e053-2995a90ab37d2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incf3e3f4c6-2cb9-7b17-e053-2a95a90a38542025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23f88c88-b68e-4706-e063-6294a90afb382025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd473113d-2fc3-6b1c-e053-2a95a90a88ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Incd89df7a5-7741-3e1d-e053-2995a90ae2752025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd4757d99-bac6-48fb-e053-2a95a90ab1bf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc24d3fbbc-0bce-b47a-e063-6394a90a9afa2025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67226-2852-0672262852001 TUBE in 1 CARTON (67226-2852-0) / 90 mL in 1 TUBE1 tube2023-01-050000-00-00NoNoCurrent
67226-2852-1672262852011 TUBE in 1 CARTON (67226-2852-1) / 250 mL in 1 TUBE1 tube2023-01-050000-00-00NoNoCurrent