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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccc43f433-51ff-ed6a-e053-2a95a90ad3c52025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb5bb6eb6-3356-e2a5-e053-2995a90aa6842025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd9cbdb4-42f1-3063-e053-2a95a90a08aa2025-12-31WarningsExact identifier
application number: M020
Eucerin Baby Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb19c82-9845-eabc-e053-2a95a90a31f72025-12-31WarningsExact identifier
application number: M020
Eucerin Advance Hydration Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd61e4d7-776d-8d84-e053-2995a90a48192025-12-31WarningsExact identifier
application number: M020
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact 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