All Calm Clinical Redness Corrector SPF 50

Product NDC
68078-023
11-digit product format
680780023
Labeler code
68078
Product ID
68078-023_2e084b9c-3859-4721-849f-15cdaf684a13
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colorescience
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-02
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
116; 86 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
All Calm Clinical Redness Corrector SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE116 mg/mL
ZINC OXIDE86 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-023-02All Calm Clinical Redness Corrector SPF 501 mL in 1 PACKETLIQUID15
68078-023-24All Calm Clinical Redness Corrector SPF 5030 mL in 1 TUBELIQUID305
68078-023-24All Calm Clinical Redness Corrector SPF 501 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-023ALL CALM CLINICAL REDNESS CORRECTOR SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]5Current NDC, Legacy NDC, 3 package rows20241222_68b95e94-3686-4d11-9952-ec86394376ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68078-023-02680780023021 mL in 1 PACKET (68078-023-02) 1 ml2017-08-020000-00-00NoNoCurrent
68078-023-24680780023241 TUBE in 1 CARTON (68078-023-24) / 30 mL in 1 TUBE1 tube2017-08-020000-00-00NoNoCurrent