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 23 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Preen Screen Broad Spectrum SPF 50	AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Grace and Fire USA Inc.	26a0fc0d-a903-2ac1-e063-6394a90a13db	2026-06-01	Warnings	Exact identifier application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	ProBetter USA, Inc.	82a22071-f1bd-4fab-b929-8a00ef18f0d9	2026-05-31	Warnings	Exact identifier application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	OSEA International, LLC	9aa20377-0ab9-4205-b9aa-24640a4641e7	2026-05-29	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Sugar	ZINC OXIDE	Ciele LLC	52f3a9f6-a226-6723-e063-6394a90a8706	2026-05-29	Warnings	Exact identifier application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	294e6049-12b5-4b45-ae00-8ee1d9d2a1a4	2026-05-29	Warnings	Exact identifier application number: M020
Daily Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	52f818f4-8485-b228-e063-6294a90a9fe3	2026-05-29	Warnings	Exact identifier application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREEN	ZINC OXIDE, OCTISALATE, HOMOSALATE	GOWOONSESANG COSMETICS CO., LTD.	30d34459-b7fb-b0c6-e063-6294a90a08ac	2026-05-28	Warnings	Exact identifier application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREEN	ZINC OXIDE	GOWOONSESANG COSMETICS CO., LTD.	30d49f24-3e13-385f-e063-6294a90ab5c8	2026-05-28	Warnings	Exact identifier application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREEN	HOMOSALATE, OCTISALATE, AVOBENZONE	GOWOONSESANG COSMETICS CO., LTD.	30d53b8a-7e35-0b2b-e063-6294a90aa8df	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Berri	ZINC OXIDE	Ciele LLC	52e16cbc-b452-db18-e063-6394a90a4081	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect June	ZINC OXIDE	Ciele LLC	52e1c504-f0ee-2853-e063-6394a90a3139	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect January	ZINC OXIDE	Ciele LLC	52e186df-06aa-6528-e063-6294a90a3888	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Berri	ZINC OXIDE	Ciele LLC	52e1398d-b170-ea89-e063-6294a90a7d24	2026-05-28	Warnings	Exact identifier application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREEN	ZINC OXIDE 20%	Fallien Cosmeceuticals, LTD	30d30610-2e6c-418c-bbcf-4ecd7f61be93	2026-05-28	Warnings	Exact identifier application number: M020
Creme Foundation	ZINC OXIDE	Lauren Brooke Cosmetiques LLC	4d09907e-ddcd-9d62-e063-6394a90acf3f	2026-05-28	Warnings	Exact identifier application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50	ZINC OXIDE	Zero to Seven Inc.	1e8720b4-5e8b-dc8b-e063-6394a90aad34	2026-05-27	Warnings	Exact identifier application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50	ZINC OXIDE	Zero to Seven Inc.	1e8727a4-0dc0-19dc-e063-6394a90a82b6	2026-05-27	Warnings	Exact identifier application number: M020
Tallow and Sol SUNSCREEN SPF30	NON-NANO ZINC OXIDE 20%	Guangzhou Shengyanghui Industrial Trading Co., Ltd	52c9dc0a-41f7-3e8a-e063-6394a90a8fca	2026-05-27	Warnings	Exact identifier application number: M020
Tallow and SolSUNSCREEN SPF50	NON-NANO ZINC OXIDE 25%	Guangzhou Shengyanghui Industrial Trading Co., Ltd	52cb56cf-f092-9f86-e063-6394a90ac2d3	2026-05-27	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen Face and Body	ZINC OXIDE	Toddle Born Wild, Inc.	e97d82fe-cd45-43a5-9c1f-3900025240a1	2026-05-27	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