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 142 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RADIANCE ZINC OXIDE L.S. MOORE LLC 37f254cb-9de5-8f67-e063-6294a90a4e28 2025-12-09 Exact identifier application number: M020 StriVectin Advanced Retinol Daily Repair Moisturizer SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. cfbdbba8-a739-fd32-e053-2a95a90a6f31 2025-12-09 Warnings Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f20c14-070e-4f86-e063-6294a90ad4c2 2025-12-09 Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f330a0-790a-1656-e063-6294a90a691c 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f2e363-e85f-f601-e063-6294a90ab120 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L MOORE AESTHETICS 37f1ac8c-3bfb-10da-e063-6294a90a8ca8 2025-12-09 Exact identifier application number: M020 RoC Multi Correxion Revive and Glow Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 40d4cfeb-fb00-801e-e063-6394a90ada6b 2025-12-09 Warnings Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f2b104-0213-c88c-e063-6294a90a4247 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Lightly Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3350c673-2afd-a00a-e063-6294a90aa196 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Dry Touch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 334ffc49-3196-0995-e063-6394a90ad559 2025-12-09 Exact identifier application number: M020 Foam Weightless Sunscreen Non-Tinted Drytouch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 335ec22c-6a9a-c4d1-e063-6394a90ac0b0 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Non-Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3360a208-5f17-a74b-e063-6294a90a13e1 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 323356ea-31a0-6ff0-e063-6294a90a135c 2025-12-09 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32330376-5db0-202b-e063-6294a90add15 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 32354468-94a2-604b-e063-6394a90adfb5 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 32346536-f542-ef0f-e063-6394a90a0464 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Untinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 3234b498-5b56-55f4-e063-6294a90a9b87 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 3235a696-92aa-788c-e063-6394a90a0149 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32351db0-884c-8fa0-e063-6294a90acba2 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 3235786d-7ba9-c9ab-e063-6294a90a7f2e 2025-12-09 Exact identifier application number: M020
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