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 159 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0e905f47-a1d8-4c5a-8247-d7328d2cb4af2025-11-21WarningsExact identifier
application number: M020
SPF 50 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inca22baebd-1f4d-6eae-e053-2a95a90afe512025-11-21WarningsExact identifier
application number: M020
Everyday Sun DefenseZINC OXIDEHommerejuvenate, Inc.05aa1a1a-9e4f-2781-e063-6394a90aef6b2025-11-21WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEWILD CHILD LABORATORIES PTY LTDdca2f4ce-1a3a-707e-e053-2995a90abad72025-11-21WarningsExact identifier
application number: M020
innisfree Daily UV Defense SunscreenAVOBENZONE, HOMOSALATE, AND OCTISALATE LOTIONInnisfree Corporation0e9b6697-28a3-f69f-e063-6394a90a9d112025-11-20WarningsExact identifier
application number: M020
SULWHASOO PERFECTING CUSHION NO. 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
application number: M020
Anti-Aging Complex Eye Treatment Merle NormanOCTINOXATE, ZINC OXIDEMerle Norman Cosmetics, Inc13381b0d-52f6-4736-b2bf-faf34d5028a82025-11-20WarningsExact identifier
application number: M020
CC Cream Broad Spectrum SPF 30 Merle NormanHOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc93ebe819-6763-400c-8320-812276168b6c2025-11-20WarningsExact identifier
application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDENorwex Usa, Inc.440bd831-ee0b-b527-e063-6294a90a93332025-11-20WarningsExact identifier
application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEElemis Ltd.23f9222f-60ba-72fb-e063-6394a90a99652025-11-20WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie RepellantZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca866e-adc3-5a4f-e063-6394a90a1d1d2025-11-20WarningsExact identifier
application number: M020
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50ZINC OXIDESunkissed By Heaven, LLC09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d2025-11-19WarningsExact identifier
application number: M020
KOVR Military grade sunscreen for womenZINC OXIDEACTIVE LIFE INC4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae2025-11-19WarningsExact identifier
application number: M020
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
application number: M020
Daily Defence Shield SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedb2b6de93-47c8-4b6e-9fb9-8bdc8909271a2025-11-19WarningsExact identifier
application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32ZINC OXIDEDUKE CANNON SUPPLY CO.0c47278b-2ec2-81ab-e063-6294a90ac9372025-11-19WarningsExact identifier
application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.03b0f2ee-526b-4513-b70a-2918ad322b5e2025-11-19WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEPARTICLE AESTHETIC SCIENCE LTD1b33b4fb-1deb-69f7-e063-6294a90a9cc02025-11-19WarningsExact 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