Home NDC 66097-009 Tinted Sunscreen Cream SPF 30 4-Deep Amber
Product NDC 66097-009
11-digit product format 660970009
Labeler code 66097
Product ID 66097-009_28f03a19-7d57-283c-e063-6394a90aa531
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 2017-03-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 129.3; 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 Cream SPF 30 4-Deep Amber
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 129.3 mg/mL ZINC OXIDE 108.9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66097-009-40 Tinted Sunscreen Cream SPF 30 4-Deep Amber 1 in 1 BOX CREAM 1 6 66097-009-40 Tinted Sunscreen Cream SPF 30 4-Deep Amber 40 mL in 1 TUBE CREAM 40 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66097-009 TINTED SUNSCREEN CREAM SPF 30 4-DEEP AMBER (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [C.F.E.B. - SISLEY] 6 Current NDC, Legacy NDC, 2 package rows 20241212_5599922a-b020-477c-a44c-1db42ec5756a.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66097-009-40 66097000940 1 TUBE in 1 BOX (66097-009-40) / 40 mL in 1 TUBE 1 tube 2017-03-15 0000-00-00 No No Current