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 198 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a9068dc0-bc48-498b-adc9-57ff810384af	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37f01f66-c604-4fc3-a263-2089db91283f	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	bca57893-bd2d-44ac-a503-2f11c3b62bf2	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37188b77-ab0b-4bea-b839-99e589600a2b	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c89e45d6-2322-4913-a557-e1780a86fd63	2025-08-11	Warnings	Exact identifier application number: M020
Sun Bum Face 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1ed89c-6d50-6400-e063-6294a90a1433	2025-08-11	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	24e9ea4d-3073-c126-e063-6394a90a7c6e	2025-08-10	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	d1c5b7a5-73f9-4df6-9469-ce42e4f33ae8	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	96efeb92-a276-4ac9-b30a-11b4fa367263	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER PEACH SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	edeb2ee1-cc84-4254-80c1-6410cd77c422	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER STRAWBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	7abe936b-a4d5-457c-9cdd-761b201bb046	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER BLUEBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	e4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	8be1c27c-7988-47c4-b613-3bc86f53981e	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRY	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	a3c8d778-ce9c-46eb-a0c3-6886eb1d3934	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	6cdb0b61-a9c2-4a78-9752-8e7aedaeef45	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINK	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	f1b6c068-06d2-4a44-8199-7111d1b6a0d6	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER COOKIE SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	0274f5f1-1ee1-48a5-af7a-deb3aa3a34d7	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER ICE MINT SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	a355777b-2cce-48ce-acc6-2aa7f154c4ba	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER RASPBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	5443202c-4f88-4063-a227-c50abbd480d6	2025-08-08	Warnings	Exact identifier application number: M020
SUNSCREEN SPF50	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE	Guangzhou Tinsun Biotechnology Company Limited	3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e	2025-08-07	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