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 217 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunstation Sport Sunscreen SPF 30 OCTISALATE, OCTOCRYLENE, ZINC OXIDE Impact Melanoma Inc ba78aa73-a25b-4a8e-99b2-9262bb9a7d27 2025-04-24 Warnings Exact identifier application number: M020 Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 42819c8d-cc0a-4bee-95db-39a69ce7f660 2025-04-24 Warnings Exact identifier application number: M020 LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 338c2c66-497a-f7d1-e063-6294a90a7789 2025-04-24 Warnings Exact identifier application number: M020 The Ordinary UV Filters SPF 45 Serum HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE Deciem 10cde253-26ee-b97d-e063-6394a90a8302 2025-04-23 Warnings Exact identifier application number: M020 BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin C ZINC OXIDE VeganicSKN 3123aab6-0407-19e5-e063-6394a90a5bd8 2025-04-23 Warnings Exact identifier application number: M020 KARYNG Complete SPF Sunscreen Light/Medium SUNSCREEN Karyng LLC 33596253-413d-fba3-e063-6394a90a39e4 2025-04-22 Warnings Exact identifier application number: M020 Sephora Daily Sunscreen Cream Broad Spectrum SPF 30 ZINC OXIDE S+ b49e043b-8164-421c-a02b-3dab0be1454d 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Sports Cream ZINC OXIDE YAYA ORGANICS L.L.C. 9eabf1f8-698b-4fa8-98d3-3696c35b044c 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Baby Kids Mineral Sunscreen ZINC OXIDE YAYA ORGANICS L.L.C. 3275303d-a448-4fb4-bdce-6442823f8996 2025-04-22 Warnings Exact identifier application number: M020 Oathology Inzincable Sunscreen SPF 50 HOMOSALATE, OCTOCRYLENE, ZINC OXIDE SKINOATH LLC d245dfca-9e32-4e71-9df8-58fff84ef6a9 2025-04-22 Warnings Exact identifier application number: M020 Back9ine Skincare Pure Invisible Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Back 9ine Skincare, LLC 974ede40-cfb5-4612-b168-5d42dd137f63 2025-04-22 Warnings Exact identifier application number: M020 KARYNG Complete SPF Sunscreen Medium/Dark SUNSCREEN Karyng LLC 335eee1e-ef1c-41da-e063-6294a90ac273 2025-04-22 Warnings Exact identifier application number: M020 Algenist OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Solazyme, Inc. 4ece1847-1c94-4bf7-b936-109556a460a7 2025-04-22 Warnings Exact identifier application number: M020 Sulwhasoo Perfecting Cushion NO.17N1 Vanilla OCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATE Amorepacific Corporation 3350f28e-22b4-904c-e063-6394a90a1c81 2025-04-21 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC c914c4cd-99a2-4d9f-8f04-8af2ace3c345 2025-04-18 Warnings Exact identifier application number: M020 Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25 ZINC OXIDE CHARLIS LLC 330f7470-0d53-7361-e063-6394a90a5d59 2025-04-18 Warnings Exact identifier application number: M020 Chardonnay Lip Oil AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Vacation Inc 1318a429-d382-f5b8-e063-6394a90a3bd4 2025-04-18 Warnings Exact identifier application number: M020 Shimmer Oil AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Vacation Inc. 131c63ba-57fc-9ce8-e063-6294a90acd92 2025-04-18 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 055431a6-e9e0-99b4-e063-6394a90acb11 2025-04-17 Warnings Exact identifier application number: M020 SILKEN pore perfecting sunscreen broad spectrum SPF 35 OCTISALATE, ZINC OXIDE TATCHA INC. 251566a1-0e21-4030-9d4e-52c4a8bd3330 2025-04-16 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