FDA.reportPublic FDA data

Continuous Correction Cream

Product NDC
84203-003
11-digit product format
842030003
Labeler code
84203
Product ID
84203-003_57f4bc0f-64d9-68b7-e063-6394a90a4bd5
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate 10% Octisalate 4.9% Octocrylene 4%
Dosage form
CREAM
Route
TOPICAL
Labeler
Baxter of California, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-29
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
100; 40; 49 mg/mL; mg/mL; mg/mL
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
Continuous Correction Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTOCRYLENE40 mg/mL
OCTISALATE49 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal 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
14b05c8c-0398-2973-e063-6394a90a8a86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84203-003-01Continuous Correction Cream30 mL in 1 TUBECREAM303
84203-003-01Continuous Correction Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84203-003CONTINUOUS CORRECTION CREAM (HOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%) CREAM [BAXTER OF CALIFORNIA, LLC]2Current NDC, 2 package rows20240620_14b05c8c-0398-2973-e063-6394a90a8a86.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 254 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUMZINC OXIDECOSMAX USA, CORPORATION298707d4-72ed-796f-e063-6294a90aa5cd2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM LIGHTZINC OXIDECOSMAX USA, CORPORATION29871c02-9adf-6266-e063-6394a90a20ab2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM TANZINC OXIDECOSMAX USA, CORPORATION29874029-24bf-b2ce-e063-6394a90acd4d2024-12-18WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.2990e4ff-5bdb-3008-e063-6294a90a94972024-12-18WarningsExact identifier
application number: M020
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29915354-4673-7444-e063-6294a90a0fd12024-12-18WarningsExact identifier
application number: M020
Mineral Lip Balm SPF-15ZINC OXIDETUBBY TODD4d938672-5302-4e47-a582-c3e6467008cb2024-12-18WarningsExact identifier
application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30ZINC OXIDESaltyface Natural Incf0cc7ce9-81b3-439f-b5ee-96138de54e782024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 JasmineTITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasole999d752-6c00-459e-b6c3-d264c330597d2024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
application number: M020
Costa Sea Mineral Sunscreen SPF 50ZINC OXIDECOSTA SEA INC841e1b3d-dbbc-4bb0-886a-fb2d077ae7392024-12-18WarningsExact identifier
application number: M020
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
application number: M020
Softlips Vanilla, Watermelon, CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company2235d029-157e-4a30-be90-605e6bc143fd2024-12-17WarningsExact identifier
application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange CranberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company0338c078-695d-4d4e-9e90-5a8a98d495242024-12-17WarningsExact identifier
application number: M020
Softlips Pearl Plus VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company107bcaa9-4347-4979-be44-35183a9ee67e2024-12-17WarningsExact identifier
application number: M020
Softlips RaspberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyd18b4c19-0365-44ec-bea8-4328e537e0d82024-12-17WarningsExact identifier
application number: M020
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
application number: M020
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84203-003-01842030003011 TUBE in 1 CARTON (84203-003-01) / 30 mL in 1 TUBE1 tube2024-03-29NoNoCurrent