Home NDC 83108-200 Rationale The Brilliance Tinted Serum SPF 50
Product NDC 83108-200
11-digit product format 831080200
Labeler code 83108
Product ID 83108-200_4b17313e-c0c5-314c-e063-6294a90a8d42
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form EMULSION
Route TOPICAL
Labeler RATIONALE GROUP PTY LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-17
Substance ZINC OXIDE
Active strength 245 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Rationale The Brilliance Tinted Serum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 245 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 83108-200-01 Rationale The Brilliance Tinted Serum SPF 50 1.5 mL in 1 PACKET EMULSION 1.5 2 83108-200-05 Rationale The Brilliance Tinted Serum SPF 50 5 mL in 1 BOTTLE, PLASTIC EMULSION 5 2 83108-200-05 Rationale The Brilliance Tinted Serum SPF 50 1 in 1 CARTON EMULSION 1 2 83108-200-15 Rationale The Brilliance Tinted Serum SPF 50 15 mL in 1 BOTTLE, PLASTIC EMULSION 15 2 83108-200-15 Rationale The Brilliance Tinted Serum SPF 50 1 in 1 CARTON EMULSION 1 2 83108-200-30 Rationale The Brilliance Tinted Serum SPF 50 30 mL in 1 BOTTLE, PLASTIC EMULSION 30 2 83108-200-30 Rationale The Brilliance Tinted Serum SPF 50 1 in 1 CARTON EMULSION 1 2
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 Sample Exclude flag Status 83108-200-01 83108020001 1.5 mL in 1 PACKET (83108-200-01) 1.5 ml 2026-02-17 Yes No Current 83108-200-05 83108020005 1 BOTTLE, PLASTIC in 1 CARTON (83108-200-05) / 5 mL in 1 BOTTLE, PLASTIC 2026-02-17 Yes No Current 83108-200-15 83108020015 1 BOTTLE, PLASTIC in 1 CARTON (83108-200-15) / 15 mL in 1 BOTTLE, PLASTIC 2026-02-17 No No Current 83108-200-30 83108020030 1 BOTTLE, PLASTIC in 1 CARTON (83108-200-30) / 30 mL in 1 BOTTLE, PLASTIC 2026-02-17 No No Current