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 287 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens 70 Hydrating Sport Broad Spectrum SPF 70 Sunscreen	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa2d08be-f67f-60dd-e053-6294a90adb3f	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 90 Sport Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa2e5b1b-f38f-11fe-e053-6394a90a4988	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 70 Sheer Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fc635082-0a7a-f160-e053-6394a90abba3	2024-10-14	Warnings	Exact identifier application number: M020
WALGREENS SPORT SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walgreen Company	a9ee1c60-6091-2229-e053-2995a90aa528	2024-10-14	Warnings	Exact identifier application number: M020
WALGREENS BROAD SPECTRUM SPORT SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	b10bdd6e-aa94-470f-8bbf-ff27a1d81938	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens Dry Touch Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	c628b15c-5fd2-fa5a-e053-2a95a90a43ac	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Hydrating Continuous	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	WALGREEN COMPANY	c8ae7f1a-d198-6609-e053-2a95a90ad462	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Mineral Sunscreen	ZINC OXIDE	WALGREEN COMPANY	d50787f1-0c50-d153-e053-2995a90add1e	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens SPF55 Sunscreen Reef-Conscious Formula	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	cfd7c1b0-cfc3-074f-e053-2995a90a5edb	2024-10-14	Warnings	Exact identifier application number: M020
Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	WALGREEN COMPANY	dfc64c7b-ee59-62a3-e053-2995a90a14a1	2024-10-14	Warnings	Exact identifier application number: M020
WALGREENS SPORT CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	e4b84304-6053-0cfe-e053-2a95a90a124a	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 50 Baby Mineral Sunscreen	ZINC OXIDE	WALGREEN COMPANY	dbee6094-e105-6d14-e053-2995a90a1528	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF55 Sunscreen Reef-Conscious Formula	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	cfd6dd4c-21f6-7cef-e053-2a95a90a50e2	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF50 Sport Sunscreen Lip Balm Reef-Conscious Formula	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TARGET CORPORATION	f8c100bd-9230-813b-e053-6294a90ae006	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TARGET CORPORATION	cfd735d2-df3a-5ed0-e053-2995a90a9f26	2024-10-14	Warnings	Exact identifier application number: M020
Target Goodfellow and Co SPF 30 Face Scent No. 05 Kelp and Sea Mineral	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	f98ee294-3ca5-18bd-e053-6394a90a9aa5	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	f9027e42-017a-07fd-e053-6294a90ab916	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TARGET CORPORATION	f99028fa-a17e-4a84-e053-6294a90a927f	2024-10-14	Warnings	Exact identifier application number: M020
Up and Up Illuminating Daily Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE	TARGET CORPORATION	9407a4a9-8a72-6a01-e053-2a95a90a231d	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up Morning Facial Moisturizing with Sunscreen Broad Spectrum SPF 30	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	TARGET CORPORATION	f9b66e3e-5493-9ea4-e053-6294a90a6063	2024-10-14	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