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 197 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3ac48eef-f651-af96-e063-6294a90a501e 2025-08-14 Warnings Exact identifier application number: M020 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Aruba Aloe Balm NV 6a398dad-2fb9-4cdb-86c5-2a392b88f29b 2025-08-13 Warnings Exact identifier application number: M020 SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40 ZINC OXIDE ALL THE RAJE, LLC 9ffbd53b-1295-42b4-9cd5-18cbb75921d0 2025-08-13 Warnings Exact identifier application number: M020 MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre ZINC OXIDE Power Beauty Co. 2e6eac42-0b70-44ea-e063-6294a90a49f8 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c414e9b-6c3e-2c8d-e063-6394a90af4a6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c443347-0134-8c87-e063-6294a90a8046 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Face Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3a22f0b9-2d6d-6230-e063-6294a90adf31 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3c4567d6-879e-f995-e063-6394a90a319f 2025-08-13 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c457455-b9b1-546b-e063-6294a90a41f6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Tinted Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c455d29-df4e-f4d5-e063-6394a90a97ba 2025-08-13 Warnings Exact identifier application number: M020 Baby Bum Mineral 50 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3c470ff8-37d6-a729-e063-6294a90aa525 2025-08-13 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen 1 OZ ZINC OXIDE Sun Bum, LLC 3c483d04-8942-5269-e063-6294a90a3881 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c49c623-47c6-4dc9-e063-6294a90a0096 2025-08-13 Warnings Exact identifier application number: M020 100% MINERAL SUNSCREEN 100% MINERAL SUNSCREEN Guangzhou Pallas Cosmetics Co.,Ltd. 3c4a3b41-9183-3835-e063-6394a90aea61 2025-08-13 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4443d4e6-bdc9-4547-9189-e94e9e0bdd2d 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC Red Correct Color Correcting SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L a6cd16cc-5fe3-41b5-b724-83e469cd4d5e 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 BRONZE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4aa12cf0-0c48-4b40-9c9a-bd50523cce8a 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 5bdaa149-47aa-40ac-b17a-ea6d29099862 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dda967c-2d69-8948-e063-6294a90ad2a4 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24e9a9b8-41ba-123a-e063-6394a90a73cb 2025-08-12 Warnings 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