FDA.reportPublic FDA data

Circadia Circa-Shield Mineral Sunscreen SPF 30

Product NDC
76458-401
11-digit product format
764580401
Labeler code
76458
Product ID
76458-401_0d1ad873-78fa-d26e-e063-6294a90a3712
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Circadia by Dr Pugliese, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-31
Substance
ZINC OXIDE
Active strength
173 mg/mL
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

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
Circadia Circa-Shield Mineral Sunscreen SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE173 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
2959aa56-be7f-4721-9701-e6d6e12cc850Available 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76458-401-00Circadia Circa-Shield Mineral Sunscreen SPF 3059 mL in 1 TUBECREAM592
76458-401-00Circadia Circa-Shield Mineral Sunscreen SPF 301 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76458-401CIRCADIA CIRCA-SHIELD MINERAL SUNSCREEN SPF 30 (ZINC OXIDE) CREAM [CIRCADIA BY DR PUGLIESE, INC.]2Current NDC, 2 package rows20231231_2959aa56-be7f-4721-9701-e6d6e12cc850.zip

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 252 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edc9-1ebd-e063-6294a90aee132024-12-25WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION29fe531e-2ade-170f-e063-6394a90a13962024-12-24WarningsExact identifier
application number: M020
SOLAR MILK SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION29fe4dad-d1fb-e750-e063-6294a90ab3072024-12-24WarningsExact identifier
application number: M020
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Incd30cc344-846d-416e-ac57-4a29d4ed82632024-12-24WarningsExact identifier
application number: M020
Almay Age Smart Shade CC Luminous Primer SPF 15ZINC OXIDE, TITANIUM DIOXIDE MAKE-UPAlmay, Inc.281557c0-e668-4436-86a7-3f583091e4e42024-12-24WarningsExact identifier
application number: M020
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcc-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Buff BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38b-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 HazelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38c-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b48b8-5953-9ab7-e063-6394a90a6b242024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcd-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich MahoganyFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-883b-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light TanFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b557a-ff60-f33f-e063-6394a90ac66f2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-8839-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b668d-036e-893e-e063-6294a90a82af2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6ba3-b5da-f2f7-e063-6394a90a86ae2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Soft NutmegFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b856a-d714-892c-e063-6294a90a4ae92024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 SandalwoodFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b856a-d712-892c-e063-6294a90a4ae92024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Tan SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b5cca-4e4f-efb6-e063-6294a90a62062024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Warm CaramelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b9147-3c7a-d549-e063-6394a90a68692024-12-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76458-401-00764580401001 TUBE in 1 BOX (76458-401-00) / 59 mL in 1 TUBE1 tube2023-12-31NoNoCurrent