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 303 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Florida Squeezed SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFlorida Squeezed13696dc6-ae64-4760-e063-6394a90ac1922024-03-11WarningsExact identifier
application number: M020
BB Noir 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs136a7f66-844c-b16a-e063-6294a90aa9752024-03-11WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral Moisture Universal TintZINC OXIDESPF Ventures, LLC12d27da2-2689-496a-e063-6294a90aaa9f2024-03-08WarningsExact identifier
application number: M020
Avene Multi-Defense FluidZINC OXIDEPierre Fabre USA Inc.1329e56d-1e74-4bcc-e063-6394a90ae0c32024-03-08WarningsExact identifier
application number: M020
Avene Multi-Defense Fluid TintedZINC OXIDEPierre Fabre USA Inc.132bdf9a-c5d0-e7e5-e063-6394a90a61802024-03-08WarningsExact identifier
application number: M020
Avene Face Sunscreen SPF 50ZINC OXIDEPierre Fabre USA Inc.132ce436-a783-2ba0-e063-6394a90a4b702024-03-08WarningsExact identifier
application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar SparkleHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLCcfd1e0c7-7e4c-41c1-8788-b73f83bf38c92024-03-06WarningsExact identifier
application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance FreeHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLC658b1b20-6540-4f3a-ac9a-170bc8fcba112024-03-06WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 15 EQBAVOBENZONE 3% OCTOCRYLENE 10%Walmarta0c452a9-3e99-41b8-b9b2-c1b57b66f1832024-03-06WarningsExact identifier
application number: M020
Target Up and Up Sport SPF 50AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb81b2e7e-6d7f-fa1d-e053-2995a90a7d152024-03-06WarningsExact identifier
application number: M020
Target Up and Up Reef Conscious Formula SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONb5fd43ee-9fa1-13c1-e053-2995a90a364a2024-03-06WarningsExact identifier
application number: M020
Vacation SPF 30 Baby OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f6030311-5287-3aa3-e053-2995a90a1b872024-03-06WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e5493f-6478-0ff4-e063-6394a90af4f52024-03-05WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil FigTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e7507d-6612-fda4-e063-6294a90a1db72024-03-05WarningsExact identifier
application number: M020
Dermachange SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPrivate Label Beauty and Wellness12f00cee-dd9b-19b1-e063-6294a90adccb2024-03-05WarningsExact identifier
application number: M020
Brush On Block Quick Stick SPF 40 Mineral StickZINC OXIDESPF Ventures LLC12d10ec9-847a-7483-e063-6294a90a42a72024-03-04WarningsExact identifier
application number: M020
Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc OxideZINC OXIDELucin Organics, LLCd717dda8-60bb-40a0-86f9-6d724d695d162024-03-04WarningsExact identifier
application number: M020
Brush On Block Bounce Butter SPF 30 Moisturizing MousseZINC OXIDESPF Ventures LLC12956754-b4e5-0203-e063-6294a90a2b962024-03-01WarningsExact identifier
application number: M020
Derma E Sun Protection Mineral SPF 30ZINC OXIDEderma ebb8e3df2-23e8-4ad0-a662-ff02d156e7b12024-02-26WarningsExact 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