Ciele lip and PROTECT lipstick SPF 60 Bonnie

Product NDC
83103-5000
11-digit product format
831035000
Labeler code
83103
Product ID
83103-5000_513a0449-5495-5dfd-e063-6394a90a026e
Type
HUMAN OTC DRUG
Nonproprietary name
Ciele lip and PROTECT lipstick SPF 60 Bonnie
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
L�E COSMETICS INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-07
Substance
ZINC OXIDE
Active strength
15 g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct83103-5000DDiscontinued by firm2026-11-06
excluded packagepackage83103-500083103-5000-1DDiscontinued by firm2026-11-06

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 lip and PROTECT lipstick SPF 60 Bonnie
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 g/100g

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
513a0449-5494-5dfd-e063-6394a90a026eAvailable on FDA.report

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83103-5000-1Ciele lip and PROTECT lipstick SPF 60 Bonnie3.5 g in 1 TUBELIPSTICK3.53
83103-5000-1Ciele lip and PROTECT lipstick SPF 60 Bonnie1 in 1 PACKAGELIPSTICK13

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 290 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clarity Rx Pucker Power lip plumper SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONETopiderm, Inc.92504982-fe0e-404d-b7cf-f6b340b898022024-07-31WarningsExact identifier
application number: M020
Essential Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.2132dc18-85ee-4449-86d2-d9f698f286c62024-07-31WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1e78109f-4d2e-2705-e063-6294a90a5ad32024-07-30WarningsExact identifier
application number: M020
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
application number: M020
Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATEDr Pawpaw Limitedf2628e3e-9eb0-49cb-91a6-d15c48cb8a192024-07-25WarningsExact identifier
application number: M020
Thinksport Daily Face SPF 50ZINC OXIDEthinkOperations,LLCb2422785-bd35-4248-a68f-fb4b1492a4cd2024-07-24WarningsExact identifier
application number: M020
Thinkbaby Clear Zinc SPF 30ZINC OXIDEthinkOperations,LLC7cd9c971-5556-42dc-af7b-3a88221b8c942024-07-24WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.0f072099-d57d-4dc4-e063-6394a90ab4382024-07-23WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.14b11b42-d1fe-572f-e063-6394a90a9eec2024-07-23WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1dda8259-4121-3c76-e063-6394a90af1892024-07-22WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.e64c8644-7af4-7b7f-e053-2995a90af7112024-07-22WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC2cecda56-4860-4d35-abc2-2bb9bdf35eae2024-07-19WarningsExact identifier
application number: M020
CVS Health SPORT SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENECVS PHARMACYf0e8c724-b377-5dc0-e053-2995a90a0d542024-07-18WarningsExact identifier
application number: M020
EQUATE Sunscreen SPORT Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INC4d819fd3-de12-4394-82f4-a48faf0b70922024-07-18WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Ultra Sport SunscreenAVOBENZONE HOMOSALATE OCTOCRYLENEBIG LOTS STORES, INC.f0e82a9f-17ac-b1c5-e053-2995a90ae07a2024-07-18WarningsExact identifier
application number: M020
Equaline SPORT Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0e8dfd4-a77c-6384-e053-2a95a90a1e4a2024-07-18WarningsExact identifier
application number: M020
TopCare Everyday SPORT Sun Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENETOPCO ASSOCIATES LLCf0e93aa8-1b09-1312-e053-2a95a90a79342024-07-18WarningsExact identifier
application number: M020
Safeway Signature Sport Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENESafeway, Inc.f557a3e2-e415-1b65-e053-2995a90a987a2024-07-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen Sport Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENETARGET CORPORATIONbad60bc1-cf78-7a33-e053-2995a90afdc32024-07-18WarningsExact identifier
application number: M020
Scar Gel SPF 35ZINC OXIDEderma e8cd263aa-a54b-4c55-b3e2-6f6763987d4a2024-07-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83103-5000-1831035000011 TUBE in 1 PACKAGE (83103-5000-1) / 3.5 g in 1 TUBE1 tube2026-05-07NoNoCurrent