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 175 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium Tint	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca1103-b9bf-2573-e063-6394a90acdc5	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Extra Sensitive	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca5334-fd41-297f-e063-6394a90ac72e	2025-10-23	Warnings	Exact identifier application number: M020
Mineral Sun Drops	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	d8acda81-4430-42f8-be56-d28bb010e630	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c34c1486-fa6c-485f-80b3-98e397b3dddb	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	74c078ec-a371-4406-8d5e-a0baada3a1a6	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Sandalwood	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2765f345-eab2-4878-b1f1-f8e243083476	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	d1181543-07ab-4a51-8b55-afc1a98293f6	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c7be3a7e-f031-4ec0-b9dc-41c025cd0066	2025-10-22	Warnings	Exact identifier application number: M020
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	41c0c262-21c3-b8e6-e063-6394a90a7c9c	2025-10-22	Warnings	Exact identifier application number: M020
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	SMASHBOX BEAUTY COSMETICS, INC	41c4e135-c6df-82d4-e063-6294a90a0ad3	2025-10-22	Warnings	Exact identifier application number: M020
City Sunscreen serum Broad Spectrum SPF 30 Supergoop	HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	a29e5a69-d17e-45ef-8dde-e99c6e4a2b22	2025-10-22	Warnings	Exact identifier application number: M020
Miffy Sunny Defense SPF Stick	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	RBGROUP Co., Ltd	24802b17-c0ba-1075-e063-6394a90addd5	2025-10-21	Warnings	Exact identifier application number: M020
Sunny Defense SPF Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RBGROUP Co., Ltd	18632155-5feb-5759-e063-6294a90ab88c	2025-10-21	Warnings	Exact identifier application number: M020
Paul Frank Sunny Defense SPF Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RBGROUP Co., Ltd	26345203-3393-60ba-e063-6394a90a7e92	2025-10-21	Warnings	Exact identifier application number: M020
Keith Haring Tone Blur Essence Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	RBGROUP Co., Ltd	1d578196-c785-9914-e063-6394a90a0533	2025-10-21	Warnings	Exact identifier application number: M020
luminous aqua sunscreen mist	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RBGROUP Co., Ltd	29fc0c2b-8d10-8704-e063-6394a90ad504	2025-10-21	Warnings	Exact identifier application number: M020
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREEN	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	DEWYTREE CO. ,LTD	2f1ca6e0-f689-57c7-e063-6394a90a3da5	2025-10-21	Warnings	Exact identifier application number: M020
TOSOWOONG Rice Glow SunScreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MANTONG Co., Ltd.	3e9120fd-1c2f-1546-e063-6394a90a9e46	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Buff	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	857666da-2b4a-4a4a-aa25-ed6fd9b6a163	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Ivory	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	62031860-2e28-4b25-82bd-29b874b24d84	2025-10-21	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