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 37 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF Lip Colour	ZINC OXIDE	Lauren Brooke Cosmetiques, LLC	50b344b5-e39d-48ef-e063-6394a90ae41c	2026-04-30	Warnings	Exact identifier application number: M020
No 7 Prime Forever SPF 50 Primer	NO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMER	Boots Retail USA	50b3e9fa-faf8-0026-e063-6294a90a0823	2026-04-30	Warnings	Exact identifier application number: M020
Tru Skin Rituals SPF 25	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	f725cd5c-999e-2393-e053-6394a90a09dc	2026-04-30	Warnings	Exact identifier application number: M020
Moisture Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	cb95975f-060d-23c2-e053-2a95a90adf1b	2026-04-30	Warnings	Exact identifier application number: M020
Day Cream SPF 30	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Anthony Skin LLC	5070e8cc-12c0-c2c4-e063-6294a90a1422	2026-04-29	Warnings	Exact identifier application number: M020
Steak n Shake Beef Tallow Sunscreen SPF 30	ZINC OXIDE	HRR Enterprises, Inc	0eb122d8-6826-4843-bed1-9e0cb8316e6d	2026-04-29	Warnings	Exact identifier application number: M020
EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walmart	509b6c7d-8a28-2d3a-e063-6394a90af068	2026-04-29	Warnings	Exact identifier application number: M020
Freaks of Nature Solar Shield Broad Spectrum SPF 30	FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30	THE FREAKS OF NATURE, INC.	509b8610-6dbe-611f-e063-6394a90a9fd1	2026-04-29	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509cad98-0321-2a0a-e063-6294a90a6ea9	2026-04-29	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509d7206-0cc1-c997-e063-6294a90a89e0	2026-04-29	Warnings	Exact identifier application number: M020
COTZ FACE MOISTURE	ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509d9a74-bc8d-c9c1-e063-6394a90a403d	2026-04-29	Warnings	Exact identifier application number: M020
JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GPNY CORP	212d4563-2fad-31a5-e063-6394a90aff71	2026-04-29	Warnings	Exact identifier application number: M020
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	GPNY CORP	211dea04-faad-8ffc-e063-6294a90a8d68	2026-04-29	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	5e19577b-9911-4fa1-a2b7-7ca2e02d1fd8	2026-04-28	Warnings	Exact identifier application number: M020
Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Ultraceuticals Pty Ltd	50888d3f-46ae-e2c2-e063-6394a90ad6af	2026-04-28	Warnings	Exact identifier application number: M020
Anything SPF	OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE	Anything SPF LLC	508b8dcb-6600-6dad-e063-6294a90a565a	2026-04-28	Warnings	Exact identifier application number: M020
Fusion Water Magic	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE	ISDIN Corp.	d4f91d5a-600a-4255-a6e1-e7e7197848c7	2026-04-28	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c6a1b995-1898-4a92-b128-7d5ebd6d8d3d	2026-04-28	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Antioxidant Protocol	AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONE	Obagi Cosmeceuticals LLC	53023b16-8d64-4dfc-bc75-b4f248425c4d	2026-04-27	Warnings	Exact identifier application number: M020
TONEfitSUN Sebum Control Vegan Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory	506b96ae-eb2a-edad-e063-6294a90a470e	2026-04-27	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