Home NDC 71883-050 Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN
Product NDC 71883-050
11-digit product format 718830050
Labeler code 71883
Product ID 71883-050_49d6e9be-72d7-1681-e063-6394a90a9d61
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octyl salicylate, Titanium dioxide, Zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler Oracle Cosmetic Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-26
Substance ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE; HOMOSALATE
Active strength 6.35; 2.25; 1.1; 3.75 g/50mL; g/50mL; g/50mL; g/50mL
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 Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 6.35 g/50mL OCTISALATE 2.25 g/50mL TITANIUM DIOXIDE 1.1 g/50mL HOMOSALATE 3.75 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 71883-050-01 Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN 50 mL in 1 TUBE CREAM 50 2 71883-050-02 Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71883-050 DR.ORACLE AIR FIT DEFENSE SOOTHING SUNSCREEN (HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ORACLE COSMETIC CO., LTD.] 1 Current NDC, 2 package rows 20240927_21424f78-f8d5-6a9b-e063-6294a90ab7dc.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 Sample Exclude flag Status 71883-050-01 71883005001 50 mL in 1 TUBE 50 ml Historical 71883-050-02 71883005002 1 TUBE in 1 BOX (71883-050-02) / 50 mL in 1 TUBE (71883-050-01) 1 tube 2024-09-26 No No Current