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 331 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	MAX HUBER RESEARCH LAB INC	ecc942c7-5495-43b1-9ffa-d38be7891152	2023-10-30	Warnings	Exact identifier application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30	ZINC OXIDE	Babo Botanicals, Inc.	08f0f32e-4b19-7a62-e063-6394a90af1b1	2023-10-30	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e5e5777c-2f67-14ed-e053-2a95a90a58a5	2023-10-30	Warnings	Exact identifier application number: M020
CoreTex Sun X SPF 30 New	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	08fb4748-d22d-35af-e063-6394a90a0827	2023-10-30	Warnings	Exact identifier application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30	ZINC OXIDE	Live Tinted, Inc.	d177b085-2bbd-49c1-b02b-a7b8d8ee0468	2023-10-28	Warnings	Exact identifier application number: M020
Live Tinted Hueguard 3-in1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30	ZINC OXIDE	Live Tinted, Inc.	cfceaf45-bab5-6858-e053-2a95a90a6be1	2023-10-28	Warnings	Exact identifier application number: M020
LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 Mins	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Live Tinted, Inc.	8e4d7c84-5acb-4857-860d-bf6837e4901e	2023-10-28	Warnings	Exact identifier application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30	ZINC OXIDE	Live Tinted, Inc.	7bceeb0e-b557-438c-88ac-0148f6eb1b4d	2023-10-28	Warnings	Exact identifier application number: M020
Green Defense daily mineral sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Farmacy Beauty LLC	d1ae2696-fd1b-4422-a8e0-5209aeeb97eb	2023-10-28	Warnings	Exact identifier application number: M020
LIVE TINTED Glow-up Hyperpigmentation Essentials	ZINC OXIDE	Live Tinted, Inc.	ef06c1eb-6ce3-4b1b-8a7d-3e29ae172844	2023-10-28	Warnings	Exact identifier application number: M020
SPF Elio Drops 30 Sheer	ZINC OXIDE	Allure Labs Inc	08c9fc56-7d4f-ebc5-e063-6294a90a5317	2023-10-28	Warnings	Exact identifier application number: M020
SPF Elio Drops 30 Glow	ZINC OXIDE	Allure Labs Inc	08cbf8d6-8c27-1567-e063-6394a90a932e	2023-10-28	Warnings	Exact identifier application number: M020
RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skin	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	ESTEE LAUDER INC	d1ca8372-28a0-41e1-b92a-913fc09f7156	2023-10-27	Warnings	Exact identifier application number: M020
Vivier Sheer SPF 30 Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Vivier Pharma, Inc.	1be5ee36-3566-495c-aae2-4d0d7fc210ed	2023-10-27	Warnings	Exact identifier application number: M020
Vivier Sheer SPF 45	ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE	Vivier Pharma, Inc.	c057138a-1111-4e7c-b94d-2ccd6bc3963c	2023-10-27	Warnings	Exact identifier application number: M020
360 by QUR Spanish lime lip balm	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Qur, Inc	bedb3347-7498-3d7a-e053-2995a90a4b12	2023-10-26	Warnings	Exact identifier application number: M020
360 by QUR Vanilla lace lip balm	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Qur, Inc	bedb4c53-adaa-3a8a-e053-2a95a90ae93a	2023-10-26	Warnings	Exact identifier application number: M020
360 by QUR Watercress mint lip balm	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Qur, Inc	bedb7413-c074-a2d7-e053-2a95a90ac5cb	2023-10-26	Warnings	Exact identifier application number: M020
PRIDEFUL SPF 15 LIP BALM-cherry vanilla	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	c827c6b4-c6d7-4585-b615-419db9520e7c	2023-10-26	Warnings	Exact identifier application number: M020
PRIDEFUL SPF 15 LIP BALM-citrus	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	2f20ee7e-3897-4263-b965-5155d89bfb5e	2023-10-26	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