FDA.reportPublic FDA data

CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 200C

Product NDC
14141-357
Requested package NDC
14141-357-01
11-digit product format
141410357
Labeler code
14141
Product ID
14141-357_27c30645-dcf0-bc31-e063-6394a90a1368
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, ZINC OXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
BEL STAR S A
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-25
Substance
OCTINOXATE; ZINC OXIDE
Active strength
40; 23.5 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 200C
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE40 mg/g
ZINC OXIDE23.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
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
27c30645-dcef-bc31-e063-6394a90a1368Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-357-01CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 200C1 in 1 BOXEMULSION11
14141-357-01CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 200C27 g in 1 TUBEEMULSION271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-357CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 140C (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 180F (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 200C (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO 320C (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110C (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO CLARO 270C (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO 380F (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 MEDIO 350N (OCTINOXATE, ZINC OXIDE) EMULSION CYZONE STUDIO 1Current NDC, 2 package rows20241127_27c30645-dcef-bc31-e063-6394a90a1368.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 293 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Care SPF 30 Facestick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONENaples Soap Co.1cfb91dc-178e-fd5d-e063-6394a90a53002024-07-11WarningsExact identifier
application number: M020
the beach people SPF 15ZINC OXIDEThe Beach People United LLC60c97b25-a23d-4f8f-bc20-0a312cbcde0e2024-07-11WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-COCTINOXATE, ZINC OXIDEBEL STAR S A1cec29ae-d402-0ee7-e063-6394a90a0a892024-07-10WarningsExact identifier
application number: M020
5298 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties667dccd6-5047-4beb-b2f0-0b8d8d79aa012024-07-10WarningsExact identifier
application number: M020
5283 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties3a06bb05-5965-4d7d-a299-3d48b163c6042024-07-10WarningsExact identifier
application number: M020
5281 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties86fc4539-e1c5-4d0f-a418-f48729cb2b202024-07-10WarningsExact identifier
application number: M020
5299 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3db6bd8-cc6f-4af5-809d-95fb05f6732f2024-07-10WarningsExact identifier
application number: M020
5407 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3f86164-2a2e-4f1f-a562-c1ff6cf503222024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.1bbf3712-b59d-cf6d-e063-6294a90af9b72024-07-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 BANANA SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5f02688-cb8a-4d9b-e053-2995a90ad1ba2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5ef831e-7c28-7c85-e053-2995a90a9e022024-07-08WarningsExact identifier
application number: M020
Equaline Sport Continuous Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENESUPERVALU INC.1cc23322-2570-75ab-e063-6394a90ad2892024-07-08WarningsExact identifier
application number: M020
Equaline Zinc Oxide Sunscreen Stick SPF 50ZINC OXIDEUnited Natural Foods, Inc. dba UNFI1cc27f99-82f3-7aee-e063-6294a90a6f372024-07-08WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a8f5d5-d3c7-4a6f-e063-6294a90a94e32024-07-02WarningsExact identifier
application number: M020
All Good Coconut SPF 20 Zinc Oxide Lip BalmZINC OXIDEElemental Herbs, Inc.fdf17ffa-681b-2809-e053-6394a90a5b6e2024-07-02WarningsExact identifier
application number: M020
Sun Shield Soft Glow Daily Face SPF30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEKoco Life LLC1c312800-4068-399e-e063-6394a90aec022024-07-01WarningsExact identifier
application number: M020
Sun on the Run KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c351485-0998-e308-e063-6394a90a9ee62024-07-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14141-357-01141410357011 TUBE in 1 BOX (14141-357-01) / 27 g in 1 TUBE1 tube2024-11-25NoNoCurrent