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 240 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut CrushAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b142875-d413-aebe-e063-6394a90aaca02025-01-06WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil Free SPF 40GLO SKIN BEAUTY OIL FREE SPF 40Hayden Caleel LLC6b27a508-8669-418f-bcb2-61a35b79a3a82025-01-05WarningsExact identifier
application number: M020
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
application number: M020
glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30Hayden Caleel LLC9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d2025-01-05WarningsExact identifier
application number: M020
Wildberry Lip BalmLIP BALMCasad Company Inc.5e13dc33-67b7-4461-bec5-0c3edc72f8b42025-01-03WarningsExact identifier
application number: M020
Iced Pear Lip BalmLIP BALMCasad Company Inc.1d9a62dd-c11e-4f97-9164-edc84adbe05b2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandalwoodZINC OXIDEEVER FAME PTE. LTD.2ace641a-b440-d0b3-e063-6394a90a86322025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SepiaZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e82d-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 TruffleZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e830-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WalnutZINC OXIDEEVER FAME PTE. LTD.2acf75d2-8ad7-1bd3-e063-6294a90ac0be2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WheatZINC OXIDEEVER FAME PTE. LTD.2acf92a1-6d2a-5517-e063-6294a90a74882025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Warm VanillaZINC OXIDEEVER FAME PTE. LTD.2acf9020-c779-31c2-e063-6294a90a1ab52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad009bc-29ce-0ba6-e063-6294a90a75802025-01-03WarningsExact identifier
application number: M020
Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad07286-f8af-7a9f-e063-6394a90a6a242025-01-03WarningsExact identifier
application number: M020
Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad0db95-a283-3c91-e063-6294a90ae5232025-01-03WarningsExact identifier
application number: M020
Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad129b7-4ecd-a967-e063-6294a90ad8c42025-01-03WarningsExact identifier
application number: M020
Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad18f4b-4251-be82-e063-6394a90acac52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad1bb50-869e-8122-e063-6294a90ac7242025-01-03WarningsExact identifier
application number: M020
Glow Baby Brightening Setting Mist SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPacifica Beauty, LLCf2f53cf9-3717-07ff-e053-2a95a90a03fb2025-01-03WarningsExact 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