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 332 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIDEFUL SPF 15 LIP BALM-passion fruitHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCd6b6389b-c8bd-4aca-8ccf-455dbc22070d2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-coconutHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCa6af5cdc-999d-45ba-a7a6-5e7330f8b9c02023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-melonHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCe201fec6-eb69-40fb-8459-02d64e34a3b72023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-orange mangoHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc50c9f00-6a0f-4307-b35d-7fc5fa3b7edf2023-10-26WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe5fcb1fd-ad61-1ea5-e053-2a95a90a24722023-10-26WarningsExact identifier
application number: M020
Grape Soda SPF 15 Broad Spectrum Lip BalmGRAPE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca09a0b5f-93e4-d18a-e053-2a95a90a65f72023-10-26WarningsExact identifier
application number: M020
Beeswax SPF 30 Broad Spectrum Lip BalmBEESWAX SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Inca962bfca-03a3-8dde-e053-2a95a90abbb92023-10-26WarningsExact identifier
application number: M020
CreamZINC OXIDEOxygen Development LLC08a1e862-b55a-fb84-e063-6294a90a016a2023-10-26WarningsExact identifier
application number: M020
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08a36887-3997-8fff-e063-6394a90ae9d52023-10-26WarningsExact identifier
application number: M020
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Unflavored Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALMRaining Roseefe20472-aa84-1cb4-e053-2a95a90abfd82023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALMRaining Roseefe1113b-6101-0c15-e053-2a95a90a02a72023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALMRaining Roseefe176f7-9c11-106e-e053-2a95a90a9c882023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Citrus Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALMRaining Roseefdfc182-3ac0-1a3d-e053-2a95a90a894e2023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Iced Pear Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALMRaining Roseefe01abd-0ee2-6bd6-e053-2a95a90a123d2023-10-26WarningsExact identifier
application number: M020
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
application number: M020
Carmex Weather Guard Moisturizing Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMCarma Laboratories, Inc.843677f2-78fa-4f3d-9fe6-e45e35b728e32023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baec9be7-5ae6-135c-e053-2995a90a2ed42023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baea3596-6eb0-4d98-e053-2995a90a75cc2023-10-25WarningsExact 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