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 68 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Centellian24 Madeca Derma Shield Vital Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e11009-ffcb-dd59-e063-6294a90add22	2026-01-27	Warnings	Exact identifier application number: M020
Sunscreen SPF50	NON NANO ZINC OXIDE	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI	c5d52f13-a649-9579-e053-2a95a90a062c	2026-01-27	Warnings	Exact identifier application number: M020
ONSART Mineral Sunscreen SPF 50	ZINC OXIDE 24%	Guangzhou Huixue Biotechnology Co., Ltd.	495e3266-a59f-42f7-e063-6394a90adfa3	2026-01-27	Warnings	Exact identifier application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	54868d6f-ae4c-476d-8c77-c4a72b13d2ea	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	dd036e0c-0c27-42b3-9d2c-33839a8631f9	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink Ice	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ea23616f-1d59-4e32-88bb-d035af727728	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic Twist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	21b6239b-26d0-4b6b-8aee-fe1f20d8aaea	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla Icing	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	483b6873-fe58-4a38-bf82-df116617c5f0	2026-01-27	Warnings	Exact identifier application number: M020
Zinc Oxide 20%	SUNSCREEN SPF 50 MINERAL	S&C Hampton Sun	4960930e-a1bf-d850-e063-6294a90a4084	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI	LE COSMETICS INC	4963658b-59bb-b313-e063-6394a90a0a51	2026-01-27	Warnings	Exact identifier application number: M020
Golden Glow SHIMMER MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	4963e513-d1fc-4b0e-e063-6394a90a7ddf	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO	LE COSMETICS INC	49644002-153f-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO	LE COSMETICS INC	49643a56-3627-67f8-e063-6294a90a2d7b	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS	LE COSMETICS INC	49644002-153e-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	496ba4c4-6577-88ff-e063-6294a90a0995	2026-01-27	Warnings	Exact identifier application number: M020
Vacation Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	b442530f-cae3-418b-9675-c18879653826	2026-01-27	Warnings	Exact identifier application number: M020
EltaMD UV Clear Blemish-Prone and Oil Balancing	OCTINOXATE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	6337b9e3-2524-4292-8fc8-1f6aad6cfe05	2026-01-27	Warnings	Exact identifier application number: M020
SPF Ginger Sunscreen SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SPF GINGER LLC	f303ad78-5fa3-40d1-9b1c-53ae1ca73aed	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP COCO-MANGO SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	8506049f-cb43-4d1d-885b-c6d3a99bbba3	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP COCO-MANGO SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	144178e7-2df9-49c3-9667-43986cee89c4	2026-01-26	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