FDA.reportPublic FDA data

Ciele Blush and Protect Berri

Product NDC
83103-2575
Requested package NDC
83103-2575-2
11-digit product format
831032575
Labeler code
83103
Product ID
83103-2575_52e1b4e7-56a9-a8fc-e063-6294a90ac826
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Ciele LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-03
Marketing end
2028-05-03
Substance
ZINC OXIDE
Active strength
88 mg/mL
NDC exclude flag
No
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
Ciele Blush and Protect Berri

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE88 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
52e1398d-b170-ea89-e063-6294a90a7d24Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83103-2575-1Ciele Blush and Protect Berri5.5 mL in 1 BOTTLE, WITH APPLICATORLOTION5.52
83103-2575-2Ciele Blush and Protect Berri1 in 1 CARTONLOTION12
83103-2575-3Ciele Blush and Protect Berri2.7 mL in 1 BOTTLE, WITH APPLICATORLOTION2.72

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 342 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
application number: M020
Thinksport Clear Zinc SPF 50ZINC OXIDEthinkOperations,LLCb5ce523f-eee8-f1a8-da19-b3dc14f8a58e2023-05-31WarningsExact identifier
application number: M020
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
application number: M020
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreeninted SPF 50ZINC OXIDETopiderm, Inc.46c6f20f-4bb6-47c6-9eac-17ca97bb14a72023-03-20WarningsExact identifier
application number: M020
Replenix Sunscreen SPF 50ZINC OXIDETopiderm, Inc.9223ffa8-7af3-4407-9170-482afec536d82023-02-24WarningsExact identifier
application number: M020
Bath and Body Works SPF20 Coconut Lip BalmSPF20 LIP BALMAutumn Harpf5744a48-2b39-4949-e053-2a95a90ab15d2023-02-24WarningsExact identifier
application number: M020
Replenix Tinted Sunscreen SPF 50ZINC OXIDE AND OCTINOXATETopiderm, Inc.1fda4a54-e323-4f3c-b659-bded4b1b3dd02023-02-22WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreen SPF 50ZINC OXIDETopiderm, Inc.ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e912023-02-22WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
application number: M020
Essential Moisturizing SunscreenZINC OXIDE, OCTINOXATETopiderm, Inc.450d916e-4c77-489e-86b1-78b6863554762023-02-09WarningsExact identifier
application number: M020
Mineral Repair SPF 45ZINC OXIDETopiderm, Inc.84580f10-3119-4253-87a6-53d24a1f22272023-02-07WarningsExact identifier
application number: M020
Think Aloe and Tea Leaves Zinc oxideZINC OXIDEthinkOperations,LLC9965ccd1-821d-4d9d-8a56-e87440b809ee2023-02-02WarningsExact identifier
application number: M020
Replenix Lip Therapy homosalateHOMOSALATETopiderm, Inc.b60dc004-d713-47bc-a6e9-ea4783aa70192023-02-02WarningsExact identifier
application number: M020
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
application number: M020
Tinted Lip Balm SPF30 Wild PeonySPF30 LIP BALMAutumn Harpd0604720-623a-e8a9-e053-2995a90ab0e62023-01-10WarningsExact identifier
application number: M020
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a39d91c-2dcf-71d6-e063-6394a90a54742022-02-10WarningsExact identifier
application number: M020
Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3a63d3-c7e0-bf03-e063-6394a90a16622022-02-10WarningsExact identifier
application number: M020
Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3c0aa0-7501-7ef0-e063-6294a90a9f942022-02-10WarningsExact identifier
application number: M020
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35OCTINOXATE AND OXYBENZONEGroupe Marcelle Inc.c24ac3ad-b2e2-4381-bd80-a499da0e06702021-12-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83103-2575-2831032575021 BOTTLE, WITH APPLICATOR in 1 CARTON (83103-2575-2) / 5.5 mL in 1 BOTTLE, WITH APPLICATOR (83103-2575-1) 2025-04-032028-05-03NoNoHistorical