FDA.reportPublic FDA data

Civant 50 Sunscreen Broad Spectrum SPF 50

Product NDC
87478-907
11-digit product format
874780907
Labeler code
87478
Product ID
87478-907_4c97b879-152c-7eae-e063-6294a90a53ad
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Civant LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-12
Substance
OCTOCRYLENE; ZINC OXIDE
Active strength
75; 100 mg/mL; mg/mL
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
Civant 50 Sunscreen Broad Spectrum SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE75 mg/mL
ZINC OXIDE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
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
e23622b8-49dd-45b9-8c51-1a83181cc7bdAvailable 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87478-907-00Civant 50 Sunscreen Broad Spectrum SPF 5094 mL in 1 TUBELOTION941
87478-907-00Civant 50 Sunscreen Broad Spectrum SPF 501 in 1 BOXLOTION11

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 133 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
application number: M020
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
application number: M020
Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC374fae34-41b9-4cab-e063-6394a90a9b1d2025-12-11Exact identifier
application number: M020
Z BlocZINC OXIDEThe Maui Medical Group, Inc34b64eb5-a91f-de43-e063-6294a90a80432025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
application number: M020
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC375008f2-8dd4-aa31-e063-6394a90a5be82025-12-11Exact identifier
application number: M020
Replenishing Daily ProtectionZINC OXIDEThe Maui Medical Group, Inc34b96d82-7fcf-e452-e063-6394a90a781b2025-12-11Exact identifier
application number: M020
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC3750ffbf-a82d-b4b9-e063-6294a90a7d682025-12-11Exact identifier
application number: M020
The BlockZINC OXIDEELITE ESTHETICS BY NICOLE CAROLINE LLC34a6b17e-6e9e-3f2c-e063-6294a90a1c322025-12-11Exact identifier
application number: M020
SPF 40 Broad Spectrum Non-TintedZINC OXIDETeton Dermatology Holdings, Inc.35093797-008b-b265-e063-6294a90a99492025-12-11Exact identifier
application number: M020
Tinted Zinc ProtectionZINC OXIDETeton Dermatology Holdings, Inc.3508d5a8-9d3c-51d1-e063-6394a90abc8e2025-12-11Exact identifier
application number: M020
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
application number: M020
Antioxidant SPFZINC OXIDETeton Dermatology Holdings, Inc.3509a916-f3e1-9c53-e063-6394a90a5bff2025-12-11Exact identifier
application number: M020
Ultimate Physical Sunscreen TintedZINC OXIDEHALEM DERMATOLOGY PLLC35bb4953-ca8c-e927-e063-6394a90a1a312025-12-11Exact identifier
application number: M020
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87478-907-00874780907001 TUBE in 1 BOX (87478-907-00) / 94 mL in 1 TUBE1 tube2026-02-12NoNoCurrent