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 224 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Obagi Skintrinsiq Firming Protocol	TITANIUM DIOXIDE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	67ba9f32-bbf4-4c14-9e97-08f1cb7d3996	2025-03-21	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Brightening Protocol	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	2f75ebf7-d6b6-45c6-ad5b-61739d260ff7	2025-03-21	Warnings	Exact identifier application number: M020
Hello Kitty Fun Broad Spectrum SPF 40	ZINC OXIDE	The Creme Shop Inc	30d37581-122c-ec92-e063-6294a90ab425	2025-03-21	Warnings	Exact identifier application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40	ZINC OXIDE	The Creme Shop Inc	30d3ed8c-f424-8d95-e063-6394a90a0cbc	2025-03-21	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	c7142781-fa57-43e5-9436-cb29dd03a669	2025-03-21	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	00ec7d9c-8550-45ce-8d0a-ef2caf84f98d	2025-03-21	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Clarifiying Protocol	SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	08ba9ea8-73fd-472b-9cc4-67df167352ec	2025-03-21	Warnings	Exact identifier application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	3e51da46-6a81-4b74-b16e-3fc298a4ba59	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	2d2c58e2-0d15-4383-adae-12fc17b8ea50	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	1907126c-fd95-86e8-e063-6394a90a23ca	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus	ZINC OXIDE	Kenvue Brands LLC	4504a10d-6130-4ec5-823a-ab970709e6d7	2025-03-20	Warnings	Exact identifier application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Eai-jr 286, Inc	30caf1dd-142d-85d3-e063-6394a90a0c88	2025-03-20	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Way to Glow Kit	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	f6f6e219-4ef6-be3b-e053-6294a90a660d	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	e8d19915-8996-42df-a47b-2ce00d2bbe68	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42	ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	21bde283-a554-45c8-8733-2a8adeff41b1	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	7a98171f-bf21-40d4-bc78-883aa0b0c438	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	5e2d7c94-d70a-47e4-9a4b-5953fe38ede2	2025-03-19	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	50206f9e-2dd5-494f-9eed-f7d7ea6efda9	2025-03-18	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