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 134 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35bc5ff5-8eb8-54cf-e063-6394a90ae3c2 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350ad191-e51c-083d-e063-6394a90aa646 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35be5dc0-861f-3738-e063-6394a90a23ca 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350b2246-6e00-38fc-e063-6294a90ae382 2025-12-11 Exact identifier application number: M020 Calming Protection SPF40 ZINC OXIDE FRESH FACED SKIN CARE LLC 35d0c081-67b4-ce46-e063-6294a90ad822 2025-12-11 Exact identifier application number: M020 Tinted Facial Protection SPF40 TITANIUM DIOXIDE, ZINC OXIDE FRESH FACED SKIN CARE LLC 35d08e2a-b118-8634-e063-6294a90a918d 2025-12-11 Exact identifier application number: M020 Total Body Block Sunscreen ZINC OXIDE THE COMPLEXIONIST 38f53f6a-8e68-e30f-e063-6394a90afef2 2025-12-11 Exact identifier application number: M020 Fair Skin Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351bb329-90ea-f19a-e063-6394a90af107 2025-12-11 Exact identifier application number: M020 Oil Free Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351b4870-d9bd-c356-e063-6394a90a7763 2025-12-11 Exact identifier application number: M020 Anti-Aging Sun Protection NT TITANIUM DIOXIDE, ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351a20df-bd8a-8ea6-e063-6294a90abaaf 2025-12-11 Exact identifier application number: M020 Tinted Primer Anti-Aging TITANIUM DIOXIDE, ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351aaaad-44ce-3558-e063-6294a90a2b46 2025-12-11 Exact identifier application number: M020 Total Body Block Sunscreen ZINC OXIDE ADR SUNCARE 38f4928c-6389-5aa1-e063-6294a90a8f9d 2025-12-11 Exact identifier application number: M020 Magic Veil ZINC OXIDE THE COMPLEXIONIST 38f574ad-c4bf-fca1-e063-6394a90a00c5 2025-12-11 Exact identifier application number: M020 Magic Veil ZINC OXIDE THE COMPLEXIONIST 38f5a0b9-bbe2-50f4-e063-6294a90a10d7 2025-12-11 Exact identifier application number: M020 Daily Tinted Antioxidant Mineral Sunscreen ZINC OXIDE MONIKA G KIRIPOLSKY MD INC. 3b3f19c1-4bff-315f-e063-6394a90a9a85 2025-12-11 Warnings Exact identifier application number: M020 Daily Repair Moisturizing Tinted ZINC OXIDE Skintique 37dd83db-aa43-7f66-e063-6294a90a893b 2025-12-11 Exact identifier application number: M020 Daily Repair Moisturizing Non Tinted ZINC OXIDE Skintique 37de01d0-7694-69c1-e063-6394a90acf0a 2025-12-11 Exact identifier application number: M020 Daily Shield Facial Primer TITANIUM DIOXIDE, ZINC OXIDE Skintique 37dd5228-5fe4-5e7b-e063-6294a90adffb 2025-12-11 Exact identifier application number: M020 Daily Repair Moisturizing Non Tinted ZINC OXIDE Skintique 37ddc177-376d-b2fe-e063-6294a90a5e07 2025-12-11 Exact identifier application number: M020 Daily Shield Facial Primer TITANIUM DIOXIDE, ZINC OXIDE Skintique 37de2f44-e0da-0d1c-e063-6294a90ae18b 2025-12-11 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