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 262 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo SPF 30 Clear Zinc Fragrance FreeMINERAL SUNSCREENBabo Botanicals, Inc.b3e40cb0-dbfd-955c-e053-2995a90af8482024-12-12WarningsExact identifier
application number: M020
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDEBABOR Cosmetics America Corp291ec801-ee15-06a4-e063-6294a90ab32b2024-12-12WarningsExact identifier
application number: M020
All Calm Clinical Redness Corrector SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColorescience68b95e94-3686-4d11-9952-ec86394376ee2024-12-12WarningsExact identifier
application number: M020
Method Men Face with Zinc Oxide SunscreenZINC OXIDEMethod Products Inc.cce5f8e1-cf40-4524-af2b-1d49309e28092024-12-12WarningsExact identifier
application number: M020
Sunforgettable Tint du Soleil Foundation SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescience219e2ef4-e977-4527-8999-14b27d5a7a332024-12-12WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50Plus SunscreenZINC OXIDEAbsolutely Natural4855c2c7-1516-4857-b103-2eb72a60d5d02024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 30 SunscreenZINC OXIDEAbsolutely Naturalb6e8f361-fd31-4f21-9095-c5159a8261752024-12-11WarningsExact identifier
application number: M020
Walgreens Scar Cream w/SPF 30AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%Walgreenscc72c8c5-f3e9-e8e0-e053-2a95a90ae0b02024-12-11WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lee9ae84b-c8fc-4a87-8910-46ec8ccfe1a92024-12-11WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG DORE SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L121aa873-5ca6-426b-8ece-dcb5a9f82a032024-12-11WarningsExact identifier
application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
application number: M020
ERBORIAN CC RED CORRECT SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELaboratoires M&L21530925-03b7-40bb-9836-6ee4011c4a792024-12-11WarningsExact identifier
application number: M020
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep HoneyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdc792777-d8b6-3ebc-e053-2a95a90abc3f2024-12-11WarningsExact identifier
application number: M020
Zoey naturals Broad Spectrum SPF 50 Fragrance Free SunscreenZINC OXIDEAbsolutely Natural6e05e060-a531-4c4a-b273-889407ec57042024-12-11WarningsExact identifier
application number: M020
Peptide Lip Shine SPF30 SunscreenZINC OXIDEColorescience, Inc.98cdf19d-8b8a-4051-88bb-79160b2af39e2024-12-11WarningsExact identifier
application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free SunscreenZINC OXIDEAbsolutely Natural082983a4-7b98-489d-8ac2-a185923b86ba2024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50 SunscreenZINC OXIDEAbsolutely Natural89657538-904d-4908-ba7b-6f84706a80012024-12-11WarningsExact identifier
application number: M020
SISLEYA Global Anti-Age Hand care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATEC.F.E.B. Sisleycddf11b1-a89b-4b54-b228-55ba8147f0222024-12-10WarningsExact 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