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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC1907126c-fd95-86e8-e063-6394a90a23ca2025-03-20WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLC4504a10d-6130-4ec5-823a-ab970709e6d72025-03-20WarningsExact identifier
application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEEai-jr 286, Inc30caf1dd-142d-85d3-e063-6394a90a0c882025-03-20WarningsExact identifier
application number: M020
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCaa937596-2378-469f-a0e1-9700044e83b32025-03-20WarningsExact identifier
application number: M020
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCe8d19915-8996-42df-a47b-2ce00d2bbe682025-03-20WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION21bde283-a554-45c8-8733-2a8adeff41b12025-03-20WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION7a98171f-bf21-40d4-bc78-883aa0b0c4382025-03-20WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDEThe Creme Shop30a4280b-4a9f-4c18-e063-6394a90a85e62025-03-18WarningsExact identifier
application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45ZINC OXIDEEai-jr 286, Inc30a5ec14-63d7-e678-e063-6294a90abb572025-03-18WarningsExact identifier
application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc88e44da-0b0e-4744-8b4b-4d9d418f29d72025-03-18WarningsExact identifier
application number: M020
MDP UV BIO SUNSCREENZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATESKINIDEA CO., LTD3087771e-2ab8-2198-e063-6294a90a37d42025-03-17WarningsExact identifier
application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.2b38da59-b83e-4285-e063-6294a90ac6a72025-03-17WarningsExact identifier
application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
application number: M020
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact 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