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 91 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact identifier
application number: M020
Bellas Friends Sunscreen StickZINC OXIDEPanergytek Usa Inc478cbdeb-28e4-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M020
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Clear SunshineZINC OXIDECyberderm Laboratories inc.a8646ee4-5e6e-6cdd-e053-2a95a90aee772026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Strawberry ZinniaZINC OXIDECyberderm Laboratories inc.a888396f-489f-7e7c-e053-2995a90aee5b2026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Watermelon LilyZINC OXIDECyberderm Laboratories inc.a8889754-8e33-4d2a-e053-2995a90a60802026-01-01WarningsExact identifier
application number: M020
OKeeffes Lip RepairAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENEThe Gorilla Glue Company/O'Keeffe's Company6805b3e9-77cb-bfee-e053-2991aa0a8d982026-01-01WarningsExact identifier
application number: M020
Walgreens 50 Pina Colada Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4978c811-be34-9fc3-e063-6394a90a2d802026-01-01WarningsExact identifier
application number: M020
Unicorn Snot 35 SPF Glitter Spritz rose gold shimmerAVOBENZONE, OCTISALATE, OCTOCRYLENEJailbreak Toys, Inc. DBA UNICORN SNOT498b7c1a-e66d-9736-e063-6394a90a47122026-01-01WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Ltdf7d5aa8a-9f4a-426b-ac9d-9690cf0103e02026-01-01WarningsExact identifier
application number: M020
MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5ZINC OXIDEFormula 7venz L.L.C.5f3cdec9-2cc2-4660-827f-d286883d907c2025-12-31WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO VACATION GLOW SPF 30ZINC OXIDESOLARA SUNCARE, INC.1f5cb694-f065-7ebc-e063-6394a90a883a2025-12-31WarningsExact identifier
application number: M020
SUNSCREEN GLOWING, SPF 30SUNSCREEN GLOWING LOTIONFSA Store Inc473bcb90-ab7f-170b-e063-6294a90a99d52025-12-31WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ba5966-f0ff-5360-e063-6294a90a0fc92025-12-31WarningsExact 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