FDA.reportPublic FDA data

Tinted Sunscreen SPF 30 2-Golden

Product NDC
66097-008
11-digit product format
660970008
Labeler code
66097
Product ID
66097-008_28f04fc2-5985-709b-e063-6294a90ad133
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
C.F.E.B. - Sisley
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-23
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
147.4; 108.9 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Tinted Sunscreen SPF 30 2-Golden
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE147.4 mg/mL
ZINC OXIDE108.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal 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
389cbce6-552c-4633-babd-7b672632f0b9Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66097-008-40Tinted Sunscreen SPF 30 2-Golden40 mL in 1 TUBECREAM406
66097-008-40Tinted Sunscreen SPF 30 2-Golden1 in 1 BOXCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66097-008TINTED SUNSCREEN SPF 30 2-GOLDEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [C.F.E.B. - SISLEY]6Current NDC, Legacy NDC, 2 package rows20241212_389cbce6-552c-4633-babd-7b672632f0b9.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 227 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2ee9b3dc-91cd-1af9-e063-6394a90a78e12025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2edc79f8-aac5-15eb-e063-6394a90a97362025-02-23WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-COCTINOXATE, ZINC OXIDEBEL STAR S Adc25651b-0e30-c325-e053-2995a90a809e2025-02-21WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-COCTINOXATE, ZINC OXIDEBEL STAR S Adc129cd6-a173-d2b3-e053-2a95a90aa04e2025-02-21WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 TintedAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeec6e7c8-17fe-f34b-e053-2995a90a78a02025-02-20WarningsExact identifier
application number: M020
DropsAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.1319d6ea-a580-79c5-e063-6394a90a4dca2025-02-20WarningsExact identifier
application number: M020
Vacation SPF 50 Super Spritz Face MistAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.f67fbe98-93ce-2882-e053-2a95a90ab7132025-02-20WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
application number: M020
Mineral SPF 30 Brush-On Sun DefenseZINC OXIDEMineral Fusion29733dba-8824-461e-be44-335d6fe50d602025-02-19WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Pina ColadaAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCedc59de7-c817-1a59-e053-2995a90a34082025-02-17WarningsExact identifier
application number: M020
Liplux SPF 30 Lip BalmCLASSICCOOLA LLCb47b5f3a-43f3-ae7a-e053-2995a90ae16d2025-02-17WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Fragrance FreeAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed207afe-0b10-74c7-e053-2a95a90a9b872025-02-17WarningsExact identifier
application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent SunscreenOCTINOXATE, OXYBENZONE, OCTISALATEThe Avon Company2e5d6c93-f091-5388-e063-6394a90ad5602025-02-17WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc31a98dc7-4b99-d845-e063-6394a90a26702025-02-17WarningsExact identifier
application number: M020
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2dff0386-e151-089a-e063-6394a90a0f532025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dffc699-3b56-2c70-e063-6294a90ae2492025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance FreeZINC OXIDECOOLA, LLCedc6048e-0ea0-41c5-e053-2a95a90a96d92025-02-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66097-008-40660970008401 TUBE in 1 BOX (66097-008-40) / 40 mL in 1 TUBE1 tube2015-12-230000-00-00NoNoCurrent