COOLA Refreshing Water Mist Sunscreen

Product NDC
21839-590
11-digit product format
218390590
Labeler code
21839
Product ID
21839-590_99d86e48-3c0f-4dec-e053-2995a90a7d05
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Gordon Laboratories, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-12-31
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
20 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-590-022021-01-29C16284748780-1ba0f9c33-20e7-a910-e053-dadaa90a0b85COOLA Refreshing Water Mist Sunscreen SPF 30
21839-590-032021-01-29C16284748780-1ba0f9c33-4a01-a910-e053-dadaa90a0b85COOLA Refreshing Water Mist Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-590-01COOLA Refreshing Water Mist SunscreenSPF 3025 mL in 1 BOTTLELIQUID251
21839-590-02COOLA Refreshing Water Mist SunscreenSPF 301 in 1 CARTONLIQUID11
21839-590-03COOLA Refreshing Water Mist SunscreenSPF 3010 mL in 1 BOTTLELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-590COOLA REFRESHING WATER MIST SUNSCREEN SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 1 package rows20191227_9aa12daf-d287-1bcf-e053-2a95a90a512c.zip
21839-590COOLA REFRESHING WATER MIST SUNSCREEN SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 2 package rows20191217_99d86e48-3c0e-4dec-e053-2995a90a7d05.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21839-590-012183905900125 mL in 1 BOTTLE25 mlHistorical
21839-590-02218390590021 in 1 CARTONHistorical
21839-590-032183905900310 mL in 1 BOTTLE10 mlHistorical