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 33 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Target Up and Up SPF 50 Coconut Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	51510195-a577-dce4-e063-6294a90a3e74	2026-05-08	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Watermelon Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	5151493a-c25a-fb59-e063-6394a90a1034	2026-05-08	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Strawberry Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	51512b9f-514d-3a29-e063-6294a90ae173	2026-05-08	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Peony Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	5151560f-350c-88c3-e063-6294a90a3492	2026-05-08	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bb65c8d7-318f-4d52-9d74-ca22ce389638	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Cassette	CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE	LE COSMETICS INC	5139cc37-62ac-514b-e063-6394a90a9ca3	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Kelly	CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY	LE COSMETICS INC	5139d3c1-83d1-2ad9-e063-6394a90a6958	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Margaux	CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX	LE COSMETICS INC	5138eb74-0223-6c1f-e063-6294a90a3bc6	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Bonnie	CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE	LE COSMETICS INC	513a0449-5494-5dfd-e063-6394a90a026e	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLou	CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU	LE COSMETICS INC	5139dab1-3c27-a59e-e063-6294a90a7096	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Puzzle	CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE	LE COSMETICS INC	513a0722-42ab-1051-e063-6294a90a8a1d	2026-05-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Saddle	CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE	LE COSMETICS INC	513a12cf-0230-6a24-e063-6394a90afb95	2026-05-07	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Banana Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	513bdfb1-6b90-dfc7-e063-6394a90a9ec2	2026-05-07	Warnings	Exact identifier application number: M020
Zinc Oxide 20.00%	SPF 50 MINERAL	Coconut Caliente Costa Rica LLC	388f1e01-0feb-4c94-88a7-13c81368c6c8	2026-05-07	Warnings	Exact identifier application number: M020
SPF 50 Kids Sunscreen	HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%	Coconut Caliente Costa Rica LLC	9839570f-eeef-4140-a6ca-9fd2c9767a5b	2026-05-07	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	67b90f00-4c82-40cd-af96-f8dedf95f8af	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7a2bd17d-0ea7-4326-9939-a747869c01d2	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a396c0eb-f91f-4732-9c20-6b25aa0634b7	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	18b21fba-f6ee-4ac5-a536-096716f51da0	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	13c34bba-f939-4aa7-9457-9d6025902e06	2026-05-06	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