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 207 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nova Bright Skin SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.1c201147-7a54-41b5-bdf0-394e3d7efc0c2025-07-01WarningsExact identifier
application number: M020
Introstem Vitiscell Facial ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.65c28ed6-649d-41d9-b214-aab6ccb02dd52025-07-01WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d049b4-557f-724a-e063-6394a90a19b32025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.2f74965f-3c84-0590-e063-6294a90af2672025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d0d165-e981-284a-e063-6294a90acace2025-06-30WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKINAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inca3dc6195-3011-4e7f-b1b0-0c815b11ba8d2025-06-30WarningsExact identifier
application number: M020
Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE AND OCTISALATELOreal USA Products Inc5712df74-5201-474b-bbfd-703f3117bd9c2025-06-30WarningsExact identifier
application number: M020
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38bff6d0-5690-3ee5-e063-6294a90a9faa2025-06-29WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
application number: M020
Orchidee Double Defense Skin ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.74b3c33f-5db5-460d-97be-fa495b6252492025-06-27WarningsExact identifier
application number: M020
GHOSTEDZINC OXIDESpoogea5b611c3-d4d3-461e-84d8-d04a29c749022025-06-26WarningsExact identifier
application number: M020
Dew MeZINC OXIDESpooge0c4b429b-7dd5-4929-95af-d02b6770f1212025-06-26WarningsExact identifier
application number: M020
Zinc FIVE-0 baby and kids mineral sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38744f77-4845-eac4-e063-6294a90af6482025-06-26WarningsExact identifier
application number: M020
NYU Langone Health Lip BalmZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd38745b55-8da5-4627-e063-6394a90a24ca2025-06-26WarningsExact identifier
application number: M020
Active Skin Repair hydrating daily sunscreenZINC OXIDEInnovacyn, Inc.1eacdde1-f990-4962-92f1-3f41a8a3b1932025-06-26WarningsExact identifier
application number: M020
CheekyZINC OXIDESpooged377379a-a1be-4acf-9df5-2ff73fb5c83d2025-06-26WarningsExact identifier
application number: M020
TheOGZINC OXIDESpoogea2f781a8-eba8-48f5-8680-9235aae8a4ff2025-06-26WarningsExact identifier
application number: M020
Reef safe - Vitamin C sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0763-74e9-3a71-e063-6394a90a46fb2025-06-25WarningsExact identifier
application number: M020
Reef safe - acne-prone sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f079c-5730-5111-e063-6394a90af2d82025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Face sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0f79-016f-71a7-e063-6394a90a92862025-06-25WarningsExact 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