FDA.reportPublic FDA data

Ciele Blush and Protect

Product NDC
83103-1513
11-digit product format
831031513
Labeler code
83103
Product ID
83103-1513_41350fb3-3ae7-0c71-e063-6294a90adfce
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Ciele
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-23
Substance
ZINC OXIDE
Active strength
73.6 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciele Blush and Protect
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE73.6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83103-1513-1Ciele Blush and Protect5.5 mL in 1 BOTTLE, WITH APPLICATORLOTION5.54
83103-1513-2Ciele Blush and Protect1 in 1 CARTONLOTION14
83103-1513-3Ciele Blush and Protect2.7 mL in 1 BOTTLE, WITH APPLICATORLOTION2.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83103-1513CIELE BLUSH AND PROTECT (ZINC OXIDE) LOTION [CIELE]2Current NDC, 3 package rows20241010_0162c891-ba2d-a78f-e063-6394a90a156c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83103-1513-1831031513015.5 mL in 1 BOTTLE, WITH APPLICATOR5.5 mlHistorical
83103-1513-2831031513021 BOTTLE, WITH APPLICATOR in 1 CARTON (83103-1513-2) / 5.5 mL in 1 BOTTLE, WITH APPLICATOR (83103-1513-1) 2023-06-23NoNoCurrent
83103-1513-3831031513032.7 mL in 1 BOTTLE, WITH APPLICATOR (83103-1513-3) 2.7 ml2025-06-26NoNoCurrent