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 14 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UV RESTORE FACE SERUM SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA	564b8070-ee59-0c24-e063-6294a90ad9a9	2026-07-10	Warnings	Exact identifier application number: M020
COCO-EVE COCONUT MILK BODY SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564b80c2-16e0-fb5f-e063-6394a90a50d2	2026-07-10	Warnings	Exact identifier application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	COSMAX USA	564b9b1f-3d5b-4349-e063-6294a90a3b77	2026-07-10	Warnings	Exact identifier application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	COSMAX USA	564ba912-c44b-4940-e063-6294a90a28fa	2026-07-10	Warnings	Exact identifier application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564bbb5f-4000-390d-e063-6294a90a408d	2026-07-10	Warnings	Exact identifier application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30	ZINC OXIDE	COSMAX USA	564bb5f9-5ac5-548b-e063-6394a90a8462	2026-07-10	Warnings	Exact identifier application number: M020
ILLUSION LUMINOUS GLOW FOUNDATION	AVOBENZONE, HOMOSALATE, AND OCTISALATE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	cf6a7e1a-7bca-439c-808a-80262f095f84	2026-07-10	Warnings	Exact identifier application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30	AVOBENZONE, HOMOSALATE, AND OCTISALATE	The Procter & Gamble Manufacturing Company	30a063fa-e537-a2c1-e063-6394a90a6a83	2026-07-09	Warnings	Exact identifier application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 Sensitive	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb971e1-34f1-ee89-e063-6394a90a52a9	2026-07-09	Warnings	Exact identifier application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb9de81-f05e-9697-e063-6394a90a69c5	2026-07-09	Warnings	Exact identifier application number: M020
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier application number: M020
Sunny C Sunscreen SPF 50	SUNNY C SUNSCREEN	MIXIK, INC.	4ed2a482-6c63-69f5-e063-6394a90ad3ee	2026-07-08	Warnings	Exact identifier application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Grace and Fire USA Inc.	24389324-19db-7eb5-e063-6394a90ad7fb	2026-07-08	Warnings	Exact identifier application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE	COSMAX USA, CORPORATION	562053d4-12bd-976e-e063-6394a90a59de	2026-07-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DERMIO DERMATOLOGY LLC	562f5b0d-6a10-305d-e063-6394a90a5980	2026-07-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Suzanne's Skin2soul LLC	562fbaa6-f93a-5ec4-e063-6294a90a9634	2026-07-08	Warnings	Exact identifier application number: M020
Sun Protection Mineral SPF 30	ZINC OXIDE	derma e	bf6474a7-a21f-49cb-86e6-e5c40dbd34c3	2026-07-08	Warnings	Exact identifier application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	AUSSIE BETTA HEALTHY CARE PTY LTD	56007d82-ff5b-6c26-e063-6294a90a09b6	2026-07-07	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Dream	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	560785f5-9126-12ba-e063-6294a90ac946	2026-07-07	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Sunkissed Berry	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	56078698-8655-12bd-e063-6294a90ad34c	2026-07-07	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