FDA.reportPublic FDA data

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
IngredientStrength
ZINC OXIDE6.35 g/50mL
OCTISALATE2.25 g/50mL
TITANIUM DIOXIDE1.1 g/50mL
HOMOSALATE3.75 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21424f78-f8d5-6a9b-e063-6294a90ab7dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71883-050-01Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN50 mL in 1 TUBECREAM502
71883-050-02Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71883-050DR.ORACLE AIR FIT DEFENSE SOOTHING SUNSCREEN (HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ORACLE COSMETIC CO., LTD.]1Current NDC, 2 package rows20240927_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 269 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coral Care SPF 30 SunscreenTITANIUM DIOXIDE 8.8%Stream2Sea2749fa0e-aed5-6c9a-e063-6294a90a2bf12024-11-19WarningsExact identifier
application number: M020
FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20ENSULIZOLENoxell Corporation82f7bff9-718e-19ea-e053-2991aa0a35602024-11-19WarningsExact identifier
application number: M020
Rimmel London Lasting Finish 25 HR Foundation SPF 20OCTINOXATERimmelcfd041e9-ed40-dc93-e053-2995a90a96992024-11-19WarningsExact identifier
application number: M020
ultimate miracle worker multi-rejuvenating spf 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPhilosophy, Inc.4387abab-ee1c-4e93-bea9-01624e8b48322024-11-19WarningsExact identifier
application number: M020
Sun Voyage KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC2732a8d2-6f56-c088-e063-6294a90af3082024-11-18WarningsExact identifier
application number: M020
Eminence Radiant Protection SPF FluidZINC OXIDEEminence Organic Skin Care002a4766-0c7e-4ec7-e063-6294a90a78d82024-11-18WarningsExact identifier
application number: M020
Eryfotona Actinica Ultralight EmulsionSUNSCREENISDIN Corp1d4b88d3-bee9-102c-e054-00144ff8d46c2024-11-18WarningsExact identifier
application number: M020
Rodan and Fields Plumping Lip SPF 28 SunscreenOCTINOXATE, ZINC OXIDERodan & Fieldsedf05ccc-4299-48d5-8f8e-01255eca11c22024-11-15WarningsExact identifier
application number: M020
Melan Mineral Antioxidant Body Mist Mineral Sunscreen SPF 30ZINC OXIDEMELAN INC.210823a0-94f9-4833-b279-fc26b90611952024-11-14WarningsExact identifier
application number: M020
Luminous Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDECLINICAL SKIN LLC26e2b82c-8d7a-7261-e063-6394a90a7c0d2024-11-14WarningsExact identifier
application number: M020
CoTZ Flawless ComplexionZINC OXIDEFallien Cosmeceuticals, LTD0973223b-e75f-4eb8-bcf1-7931b30b7b512024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical Environmental Skin ProtectantDIMETHICONEFallien Cosmeceuticals, LTD84a3299d-9b98-492e-a83f-ebd72ec58f8d2024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTDc52a1e04-f3ca-47a1-a26e-d6f5e77b47d62024-11-14WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe7af4f58-90c8-2987-e053-2995a90a416b2024-11-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLC143e0a1d-305f-9015-e063-6294a90aa0252024-11-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05cb5a91-205f-b652-e063-6294a90a06642024-11-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC18e40353-5c95-4d64-e063-6394a90a017c2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLCe0ed4537-8146-45e8-e053-2995a90ac51b2024-11-12WarningsExact identifier
application number: M020
Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 SunscreenZINC OXIDEArbonne International, LLCc172f793-3f7a-47b3-9db1-58487b8ad66c2024-11-12WarningsExact identifier
application number: M020
Hello Sunday The Everyday One Face Moisturiser SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7e1aa2-7054-435d-e063-6394a90a2d082024-11-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71883-050-017188300500150 mL in 1 TUBE50 mlHistorical
71883-050-02718830050021 TUBE in 1 BOX (71883-050-02) / 50 mL in 1 TUBE (71883-050-01) 1 tube2024-09-26NoNoCurrent