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 102 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cream	ZINC OXIDE	MONAT GLOBAL CORP	e9231470-9292-0e70-e053-2a95a90a767a	2025-12-26	Warnings	Exact identifier application number: M020
Cream	ZINC OXIDE	MONAT GLOBAL CORP	e92288bb-739a-2f73-e053-2995a90ac01f	2025-12-26	Warnings	Exact identifier application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE	StriVectin Operating Company Inc.	232cbde4-d8ea-4831-9b44-c2e93203260a	2025-12-26	Warnings	Exact identifier application number: M020
Cardon	AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE	Cardon, Inc	72ee2c06-242e-29a2-e053-2991aa0ad8dc	2025-12-26	Warnings	Exact identifier application number: M020
OUHOE Water-Permeable Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46e63e1e-7851-ca26-e063-6394a90a9b53	2025-12-26	Warnings	Exact identifier application number: M020
OUHOE Sun Milk	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46e678dd-13c5-b317-e063-6294a90aa989	2025-12-26	Warnings	Exact identifier application number: M020
Dermatone Sport SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%	Dermatone Labs LLC	0e60e5bb-b941-4114-933a-29480bff5960	2025-12-24	Warnings	Exact identifier application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural	AVOBENZONE, OCTISALATE, OCTINOXATE	Intelligent Elixirs, LLC	287a61d8-0056-6211-e063-6394a90aa3da	2025-12-24	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the face	HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b5997-d229-60ee-e063-6394a90a68db	2025-12-23	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen for the face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451bcab9-9b75-a17c-e063-6294a90aafd9	2025-12-23	Warnings	Exact identifier application number: M020
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY	AVOBENZONE, OCTINOXATE, OCTISALATE	KOS America, Inc.	81352963-36ec-4099-af51-3498d89f3077	2025-12-23	Warnings	Exact identifier application number: M020
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops	ZINC OXIDE, OCTINOXATE	Longway Technology(Guangzhou)Co.,Ltd.	451b4d37-99e2-8e4f-e063-6294a90a51bb	2025-12-23	Warnings	Exact identifier application number: M020
Reclaim Revolutionary Anti-Aging Day SPF15	OCTINOXATE, OCTISALATE, AND OXYBENZONE	Guthy-Renker LLC	4b735c91-f650-4531-8744-c211d57a3e28	2025-12-23	Warnings	Exact identifier application number: M020
SCINIC ENJOY SUPER MILD SUN ESSENCE EX	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ELEVEN STREET	35272744-8253-046c-e063-6394a90aabc2	2025-12-22	Warnings	Exact identifier application number: M020
TINTED FACIAL SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1259035e-9196-97de-e063-6394a90a9dec	2025-12-22	Warnings	Exact identifier application number: M020
SUNSCREEN LIP BALM	ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE	Guangzhou Tata Biotechnology Co., Ltd.	0f8e08bf-4b14-bdad-e063-6394a90a34e1	2025-12-22	Warnings	Exact identifier application number: M020
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE	Guangzhou Tata Biotechnology Co., Ltd.	1c32b019-a038-eb61-e063-6394a90a45f2	2025-12-22	Warnings	Exact identifier application number: M020
SPF 50 MINERAL SUNSCREEN LIP	ZINC OXIDE , TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1c6f0964-9bee-1c06-e063-6294a90ac2a4	2025-12-22	Warnings	Exact identifier application number: M020
Absolut Skin SPF 50 Moisturizing Sunscreen	ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENE	Guangzhou Tata Biotechnology Co., Ltd.	3264543c-e8f5-da9a-e063-6394a90ac8c6	2025-12-22	Warnings	Exact identifier application number: M020
Firmarine Moisturizer SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	Erno Laszlo, Inc.	073f8b95-6f46-4341-817f-22f5b4f32542	2025-12-22	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