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
Ingredient	Strength
ZINC OXIDE	6.35 g/50mL
OCTISALATE	2.25 g/50mL
TITANIUM DIOXIDE	1.1 g/50mL
HOMOSALATE	3.75 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup
V06SV4M95S	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
21424f78-f8d5-6a9b-e063-6294a90ab7dc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71883-050-01	Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	50 mL in 1 TUBE	CREAM	50		2
71883-050-02	Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	1 in 1 BOX	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71883-050	DR.ORACLE AIR FIT DEFENSE SOOTHING SUNSCREEN (HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ORACLE COSMETIC CO., LTD.]	1	Current NDC, 2 package rows	20240927_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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Medicated Lip Balm Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Sport SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	57c35631-42d3-4c6c-bcbb-e2de92b45b13	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	5f09503e-c455-4ac2-8d07-e8e66c2daa32	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	b5ca4bed-4f89-4020-a055-9d11f4cd5058	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	e5fffd20-1d22-485a-9311-4cb4f9264f6f	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	404990e4-9499-4186-b39d-afc31834d334	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	6028e210-a8a3-4d84-a462-16a414c31052	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e8	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	00f0f30d-236a-fd45-e063-6294a90a747d	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted Berry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	bab8447b-58b8-4160-a91e-05f9fd09ed1d	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	MAKEUP ART COSMETICS	fb59afc1-1dc9-f783-e053-6394a90a196b	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30	ZINC OXIDE	Mary Kay Inc.	0e9b15e4-e59c-f266-e063-6394a90ab81c	2024-12-17	Warnings	Exact identifier application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	MAKEUP ART COSMETICS	e5fd3e40-de1d-4cdd-b725-4a517514ca35	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	2d034810-7210-4ad4-be23-ec2100f8c2f1	2024-12-17	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	acda1640-0d35-43dc-8734-d47b00cc85ed	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Foundation Primer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Mary Kay Inc.	59d25b44-1adb-4790-8ce6-2d847a06b8b3	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	cf7fb8f0-483d-443b-b381-086a255f0783	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	0a9ee359-19c1-4266-8a51-a68f655de151	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	d459e2f7-dc78-4519-9733-01495fc447a2	2024-12-17	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	2982ce67-f136-b93b-e063-6394a90a81ac	2024-12-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71883-050-01	71883005001	50 mL in 1 TUBE	50 ml				Historical
71883-050-02	71883005002	1 TUBE in 1 BOX (71883-050-02) / 50 mL in 1 TUBE (71883-050-01)	1 tube	2024-09-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	Oracle Cosmetic Co., Ltd. \| Kolmar Korea Co., Ltd	2026-02-02	HUMAN OTC DRUG LABEL	2