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 194 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olay Complete Hydrating with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	3ccd2703-c410-74b7-e063-6294a90a7f88	2025-08-20	Warnings	Exact identifier application number: M020
SEYE	ZINC OXIDE AND TITANIUM DIOXIDE CREAM	Guangzhou Seye Biomedical Technology Co., Ltd.	3cce91b1-311b-4c95-e063-6294a90a2d7a	2025-08-20	Warnings	Exact identifier application number: M020
Sun Bum Day Tripper - SPF 30 Moisturizing Sunscreen 3 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3ccfb90a-5976-4b38-e063-6294a90a123a	2025-08-20	Warnings	Exact identifier application number: M020
Sun Bum Day Tripper - SPF 30 Sunscreen Lip Balm (Coconut) 0.15 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cd3ce69-becc-41b7-e063-6394a90a2782	2025-08-20	Warnings	Exact identifier application number: M020
Lip Therapy Soothe and Protect Lip Treatment Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Obagi Cosmeceuticals LLC	4838679b-f510-440b-8670-a10c05ebed9b	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New	ZINC OXIDE	Sun Bum, LLC	3b8e1d73-b023-cfbd-e063-6294a90ae29d	2025-08-19	Warnings	Exact identifier application number: M020
Olay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-Free	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	8de31db2-46cf-7178-e053-2995a90a5024	2025-08-19	Warnings	Exact identifier application number: M020
Lip Balm - Variety Pack (Target) - Banana (4)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cbcae23-9b38-edaa-e063-6294a90a2e8f	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30	ZINC OXIDE	Sun Bum, LLC	3cbeb4ce-6d7c-387c-e063-6394a90af790	2025-08-19	Warnings	Exact identifier application number: M020
Olay Total Effects Moisturizer Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	The Procter & Gamble Manufacturing Company	8de52cb2-b4d2-1e0d-e053-2995a90a5aca	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen Lip Balm	ZINC OXIDE	Sun Bum, LLC	3cbfba65-5702-50b5-e063-6394a90a409d	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50	ZINC OXIDE	Sun Bum, LLC	324e8ddb-89d2-08ca-e063-6294a90ab6c1	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b02811d-dc66-fc6f-e063-6294a90aefc8	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b058b74-27d0-8f8a-e063-6294a90aa02c	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit Extract	ZINC OXIDE	Supergoop LLC	3ca7e1ed-7cc7-76b0-e063-6394a90ade93	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZ	ZINC OXIDE	Sun Bum, LLC	3b91a7e3-ce52-6aa0-e063-6394a90a15e7	2025-08-18	Warnings	Exact identifier application number: M020
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca8742f-67cb-a25c-e063-6394a90a4638	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b154009-9c6f-eadf-e063-6394a90ae424	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b162348-0222-490e-e063-6394a90ad494	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b169860-66bc-dd02-e063-6294a90a7974	2025-08-18	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