Petroleum-Free Lip Balm

Product NDC: 53329-092
11-digit product format: 533290092
Labeler code: 53329
Product ID: 53329-092_40c101e4-f9c5-4766-e063-6294a90aaa46
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Oxybenzone
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-04-01
Substance: OCTINOXATE; OXYBENZONE
Active strength: 2; 4.5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53329-092		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53329-092	53329-092-83	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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: Petroleum-Free Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2 g/100g
OXYBENZONE	4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	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
6125d98a-6fc7-4f50-924e-3b1f7ee951f4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-08-08	092 Curad Petroleum-Free Lip Balm
2023-08-08	092 Curad Petroleum-Free Lip Balm
2023-07-28	092 Curad Petroleum-Free Lip Balm
2023-07-28	092 Curad Petroleum-Free Lip Balm
2022-09-27	092 Curad Petroleum-Free Lip Balm
2022-09-27	092 Curad Petroleum-Free Lip Balm
2022-07-29	092 Curad Petroleum-Free Lip Balm
2022-07-29	092 Curad Petroleum-Free Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-092-83	Petroleum-Free Lip Balm	4.2 g in 1 CONTAINER	LIPSTICK	4.2		8
53329-092-83	Petroleum-Free Lip Balm	1 in 1 BOX	LIPSTICK	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-092	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, LP]	7	Current NDC, Legacy NDC, 2 package rows	20241204_6125d98a-6fc7-4f50-924e-3b1f7ee951f4.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 238 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ECLIPSE SPF 50 ALL SHADES	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	49df51e6-be9a-41be-b3e1-bfc062aaceaa	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	44a6ff9b-8067-4f32-acb2-4ede54c79e6e	2025-01-09	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSED	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	c45b59d8-0196-4dce-bfaa-57c47f655fe8	2025-01-09	Warnings	Exact identifier application number: M020
TiZO Tinted Lip Protection SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1088fbf6-5790-490d-b272-ec281b4b76fa	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	f106f52b-2157-46c7-9f7c-50f43a649050	2025-01-09	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKS	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	5c98bacb-8bbd-47b8-8987-50be1ed34fc0	2025-01-09	Warnings	Exact identifier application number: M020
CoTZ Face Moisture	ZINC OXIDE	Fallien Cosmeceuticals, LTD	db682516-6c8f-4009-a9ec-e21dfc64ce15	2025-01-09	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light Medium	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	bcd22c9a-2db6-4653-9ab5-825f3f5cc420	2025-01-08	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	c66c2a54-97c8-4904-a44a-b3cf790837f5	2025-01-08	Warnings	Exact identifier application number: M020
Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Tempo Industries, Inc.	af9aa56d-2f8a-55b9-e053-2a95a90a3258	2025-01-08	Warnings	Exact identifier application number: M020
Baby Mineral Sunscreen Probiotics SPF55	ZINC OXIDE	Hello Bello	0191b2e4-bcc5-541a-e063-6294a90a0e78	2025-01-08	Warnings	Exact identifier application number: M020
Kids Face and Body Sunscreen SPF 50	ZINC OXIDE	Hello Bello	01cc4ea0-e3de-32f1-e063-6394a90a1375	2025-01-08	Warnings	Exact identifier application number: M020
Baby Mineral Sunscreen SPF55	ZINC OXIDE	Hello Bello	0190eeaf-c5a0-3253-e063-6294a90a43c4	2025-01-08	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	ZINC OXIDE	Hello Bello	01cc205b-a345-262a-e063-6394a90a955c	2025-01-08	Warnings	Exact identifier application number: M020
Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen Unscented	ZINC OXIDE	Eco Lips, Inc.	febabad6-0bf2-a3f8-e053-6294a90a3aeb	2025-01-08	Warnings	Exact identifier application number: M020
LESS EVERY TONE SPF 30	ZINC OXIDE	Happy Farm Botanicals, Inc.	e91ded4b-987d-17a8-e053-2995a90adc2e	2025-01-08	Warnings	Exact identifier application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ETHEREAL AESTHETICS LLC	065d17cf-bea5-137f-e063-6394a90aeeb3	2025-01-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	SERRAO, E JOHN MD FACOG	fea61544-6684-ad34-e053-6294a90a48f3	2025-01-08	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	New Beginnings Tattoo Removal	fea87de3-116f-4774-e053-6394a90a0aad	2025-01-08	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-092-83	53329009283	1 CONTAINER in 1 BOX (53329-092-83) / 4.2 g in 1 CONTAINER	1 container	2010-04-01	0000-00-00	No	No	Current