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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tanning Club Mineral Sunscreen SPF 30	ZINC OXIDE	Tanning Club LLC	d674ccbc-7bae-435c-a531-a79e569e69a9	2026-02-04	Warnings	Exact identifier application number: M020
Derma B Everyday Fit Sunscreen SPF 50	AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NeoPharm Co., Ltd.	ba38a43d-7a8a-4814-ba34-0e99124f5fca	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	86630e82-f249-4866-82dd-3e21feb266c4	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	42adc51f-f500-485d-82a0-126672141262	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	60e55ebb-47b8-465e-819a-af195952e1ca	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f644c67b-3a71-411b-b321-39a8b18af0c7	2026-02-04	Warnings	Exact identifier application number: M020
cle de peau BEAUTE UV PROTECTIVE N	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	4b242b76-8aed-4939-9906-741828acd815	2026-02-04	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	efcf240f-95cb-45e0-b58a-9c8f3609aa55	2026-02-04	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	270ecc83-4262-4102-a753-2acaf11360a0	2026-02-04	Warnings	Exact identifier application number: M020
Walgreens 50 Caramel and Pistachio Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	4a038017-9f15-b4b2-e063-6294a90a1b23	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Shiseido Americas Corporation	ce6a28c1-56e6-4105-bc9d-9d1986ead420	2026-02-04	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	d52e2c61-edbc-4c26-b1a7-e8eb656db188	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	d365ed6d-a92f-473b-be19-b8b63d17f3b7	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	0a3b4597-06fe-4689-9751-6577867d755e	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	b83ea476-fa32-4405-9ae3-f294836edb62	2026-02-04	Warnings	Exact identifier application number: M020
Sunplus SPF50 Face Body Sunscreen	SUNSCREEN	I.Shay Cosmetics	26d55baf-66dc-b1b8-e063-6394a90a670d	2026-02-04	Warnings	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	351217c4-8d71-41d9-ab08-c43857c0510c	2026-02-04	Warnings	Exact identifier application number: M020
NIDA Invisible Fit Sun Stick	SUN STICK	Proso Corp	49eca4f2-aae3-a0d5-e063-6394a90ab25f	2026-02-03	Warnings	Exact identifier application number: M020
Shiny Hiny SPF 45 Mineral Sunscreen	ZINC OXIDE	Shiny Hiny Products, LLC	31adde36-5e1b-40ff-e063-6294a90a6f2e	2026-02-03	Warnings	Exact identifier application number: M020
Walgreens 50 Passion Fruit Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	49f030d8-959c-a3cd-e063-6294a90ae1ba	2026-02-03	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