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 198 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dd9fe59-9e40-fd06-e063-6394a90a4ca2 2025-08-12 Warnings Exact identifier application number: M020 Coola Anti-Aging Hand Cream Sunscreen AVOBENZONE, OCTOCRYLENE, OCTISALATE COOLA LLC 3c2fbf10-d68e-c601-e063-6294a90a09a3 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24ea340a-06cd-b085-e063-6394a90adff9 2025-08-12 Warnings Exact identifier application number: M020 AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 15536331-fec5-4daa-824d-2e32d63e6452 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddad045-7703-ea7e-e063-6394a90a2a5a 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 0cf45fbf-b257-f16a-e063-6294a90a8794 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddb1f53-69dd-643a-e063-6394a90ad600 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40 ZINC OXIDE Earth Mama Angel Baby LLC 908c41fd-0496-4237-813b-1135e10ae0c5 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Earth Mama Angel Baby, LLC 74475fba-4cdd-4b27-8ea4-646f4016580c 2025-08-12 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 25 ZINC OXIDE Earth Mama Angel Baby, LLC 2aa44439-663a-400b-b432-e2dc5ac2a3d1 2025-08-12 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 40 ZINC OXIDE Earth Mama Angel Baby, LLC afc88e77-a4a1-49ec-b021-bb468fd0ac68 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 31049b45-0f5e-58b6-e063-6394a90ae52c 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40 ZINC OXIDE Earth Mama Angel Baby LLC bd71a814-c0b4-428b-987e-72f7f55f998f 2025-08-12 Warnings Exact identifier application number: M020 earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40 ZINC OXIDE Earth Mama Angel Baby, LLC e9a88a57-5733-489d-a459-dd74c04daff2 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddae545-99db-144b-e063-6294a90adae5 2025-08-12 Warnings Exact identifier application number: M020 Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3aa05afb-c843-f38f-e063-6294a90a1cdf 2025-08-12 Warnings Exact identifier application number: M020 Sun Bum High Performance Sunscreen Signature Clear 50 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Sun Bum, LLC 390c6afd-e2be-414c-e063-6294a90ae119 2025-08-12 Warnings Exact identifier application number: M020 Sun Bum 30 Premium Mosturizing Sunscreen 1 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c32d2c0-0dbe-42e3-e063-6294a90aa993 2025-08-12 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c342e57-cf85-b423-e063-6394a90a61b9 2025-08-12 Warnings Exact identifier application number: M020 MATTE UNIVERSAL TINTED MOISTURIZER SPF46 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC 8e284afd-b90f-41d5-b334-e5cf4440b4d3 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