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 333 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex 10 Count Variety Pack SPF 15 SunscreenOCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.bacc60ec-0b6a-4ba2-b246-a59694f06b772023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Tropical Colada SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.d5538bd0-4bab-4401-a0b8-632809a1e04c2023-10-25WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.5720bd35-de4a-4db4-a4df-0fbc59719bfd2023-10-25WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated SPF 15OCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.ca20b2dc-97e5-461a-94c8-5c109cd152852023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.aeea02a0-233e-43b6-b1b8-95ae64b7fa002023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.41e4fca8-22c0-4a8a-95d3-e4aad559548a2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Honey Dew Melon SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2f721ae7-1922-4463-bb5f-64699907a6692023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.6ef888a3-77c0-498f-92c4-d482cf96ef462023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.4e868b1a-7c47-45de-83cd-0bd5fbb05a272023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.a298815d-9f1f-419d-9dad-6bbfcddc7a482023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb6086c1-f775-70ed-e053-2995a90a531e2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Sweets SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb62d499-1d78-1324-e053-2a95a90abe3c2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.f3eb98dc-9ab3-4123-9490-a1bbf9b3259a2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb132025-658f-d6f8-e053-2995a90a089b2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2caa7b23-2adb-4953-b044-1b1ad9a5798b2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bae876db-e410-64f6-e053-2995a90a9ebe2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb029c71-4f07-2754-e053-2995a90a7c782023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb28c2e7-4189-fc11-e053-2995a90a92ad2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Favorites SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb611c57-a8ac-0c23-e053-2995a90a5b402023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bbf118c0-7cd5-5a82-e053-2a95a90ac8c82023-10-25WarningsExact 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