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 306 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clove Hill acne safe mineral sunscreen SPF 40	ZINC OXIDE	Clove Hill LLC	a06e6393-13c5-48b9-909a-3bdf7d58cad3	2024-01-22	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	A-S Medication Solutions	bfb1fdbe-883f-4d1d-9131-a46da9827788	2024-01-18	Warnings	Exact identifier application number: M020
LA Bodies Eclipse Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	SAMSON PHARMACEUTICAL	ce3a5ddc-9d4d-4d63-879c-fc4aef9a0a0a	2024-01-18	Warnings	Exact identifier application number: M020
Shunly Zn20 Light Moisturizer	ZINC OXIDE	Shunly Skin Care LLC	d5710d48-0a4b-49a6-b6b5-9a192afccd2a	2024-01-17	Warnings	Exact identifier application number: M020
Shunly Zn20 Tinted Light Moisturizer	ZINC OXIDE	Shunly Skin Care LLC	c046eef3-c2d7-42e6-a5ad-98e513fdb4e1	2024-01-17	Warnings	Exact identifier application number: M020
Shunly Radiant Translucent SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care LLC	20783833-ee7f-4425-b4ab-ab61cda5b2c8	2024-01-17	Warnings	Exact identifier application number: M020
LA Bodies Eclipse Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	SAMSON PHARMACEUTICAL	48708273-764d-4139-ae06-7cf1a273759c	2024-01-17	Warnings	Exact identifier application number: M020
Shunly Radiant Translucent Tinted SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care LLC	1aeb5e05-730c-4c5c-b164-ad9347b0cd93	2024-01-17	Warnings	Exact identifier application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	4a243c9f-ca88-47fb-8777-1da79c001c73	2024-01-16	Warnings	Exact identifier application number: M020
NYX Professional Makeup Bare with Me Daily Moisturizing Primer with Cannabis Sativa Seed Oil SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	7f960d4c-ad09-4dc8-b272-66e4df26ace8	2024-01-16	Warnings	Exact identifier application number: M020
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN	HOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACID	Sled Distribution, LLC	ec252876-7205-83ec-e053-2a95a90a1463	2024-01-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE	Cosmetique Active Production	fd2541e1-c409-40a8-9e3f-6ff69084ea66	2024-01-15	Warnings	Exact identifier application number: M020
Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	6296fbce-93fe-483e-bd60-6ae228afcaad	2024-01-15	Warnings	Exact identifier application number: M020
LOreal Paris AntiSagging Plus Even Tone Collagen Expert Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	db483af0-797b-4ef5-b02a-ab9fa1ba87fe	2024-01-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	bc72048a-4786-44c2-97ce-022082281654	2024-01-15	Warnings	Exact identifier application number: M020
Caring mill Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FSA Store Inc.	0ec201dc-c262-cecd-e063-6394a90a3fd3	2024-01-12	Warnings	Exact identifier application number: M020
Caring mill Kids Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE,	FSA Store Inc.	0ec21837-d4f1-0916-e063-6294a90a2199	2024-01-12	Warnings	Exact identifier application number: M020
CERAMIDE LIFT and FIRM EYE SPF 15	OXYBENZONE, OCTINOXATE	REVLON	b22f0c13-0a9c-7d38-e053-2a95a90a0ecd	2024-01-12	Warnings	Exact identifier application number: M020
Elizabeth Arden, Great 8, Moisturizer SPF 35	AVOBENZONE, OCTISALATE, HOMOSALATE	Revlon	b1b89565-7292-45eb-e053-2a95a90ae8d0	2024-01-12	Warnings	Exact identifier application number: M020
CERAMIDE LIFT and FIRM	OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTISALATE, OCTOCRYLENE	REVLON	b20ae6e9-de6e-0059-e053-2a95a90a5760	2024-01-12	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