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 129 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Canopy Untinted	ZINC OXIDE	BORREGO SPRINGS SKINCARE LLC	35824cd5-0036-7886-e063-6394a90ae678	2025-12-12	Exact identifier application number: M020
Canopy SPF 40 Tinted	ZINC OXIDE	BORREGO SPRINGS SKINCARE LLC	358319c5-ae35-cb3b-e063-6394a90ad77f	2025-12-12	Exact identifier application number: M020
Non-Tinted Matte Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Philosophy by Kelly	3581ab49-ef55-3743-e063-6394a90a3bd5	2025-12-12	Exact identifier application number: M020
Matte Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Philosophy by Kelly	3581cf33-3520-42f7-e063-6394a90a6f93	2025-12-12	Exact identifier application number: M020
Mineral Sunscreen For Face and Body	ZINC OXIDE	Skin Philosophy by Kelly	358248e6-16cf-6f9b-e063-6394a90a55d7	2025-12-12	Exact identifier application number: M020
Replenishing Mineral Sunscreen	ZINC OXIDE	Skin Philosophy by Kelly	35828e76-66db-49de-e063-6294a90a2b99	2025-12-12	Exact identifier application number: M020
Matte Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Philosophy by Kelly	3592b2c7-295a-7c60-e063-6394a90a387b	2025-12-12	Exact identifier application number: M020
Mineral Sunscreen For Face and Body	ZINC OXIDE	Skin Philosophy by Kelly	3592fd5f-13d1-9aec-e063-6394a90abd67	2025-12-12	Exact identifier application number: M020
Replenishing Mineral Sunscreen	ZINC OXIDE	Skin Philosophy by Kelly	359371f2-2407-e1a1-e063-6294a90a2165	2025-12-12	Exact identifier application number: M020
Non Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	397fc3c9-9d30-adcf-e063-6394a90ac761	2025-12-12	Exact identifier application number: M020
Non Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	39800bf1-e01a-e1c8-e063-6294a90a53bf	2025-12-12	Exact identifier application number: M020
Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	397130ea-dfad-ecd3-e063-6394a90a7da4	2025-12-12	Exact identifier application number: M020
Tinted Sheer Mineral Zinc Sunscreen	ZINC OXIDE	SKIN THERAPY PLLC	39716532-a699-63b7-e063-6294a90aa0f0	2025-12-12	Exact identifier application number: M020
Sun Elegant Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BY NESRIN	3580ae10-1867-cb68-e063-6394a90a72df	2025-12-12	Exact identifier application number: M020
Simply Zinc Mineral Sunscreen Tinted	ZINC OXIDE	SKIN BY NESRIN	3580da4f-116d-8108-e063-6294a90a7bf4	2025-12-12	Exact identifier application number: M020
PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	The Beez Kneez Skin Care & Acne Clinic LLC	358195c0-6d28-1ffe-e063-6394a90a6027	2025-12-12	Exact identifier application number: M020
PROTECTOR SOLAR TINTED SPF SUNSCREEN	ZINC OXIDE	The Beez Kneez Skin Care & Acne Clinic LLC	3581d973-ac0b-7d2e-e063-6294a90ae2b3	2025-12-12	Exact identifier application number: M020
Matte Velvet Tint	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	3583f860-664b-2658-e063-6394a90a3857	2025-12-12	Exact identifier application number: M020
Satin Tint	ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	35920108-7f8a-27d4-e063-6294a90a0ef6	2025-12-12	Exact identifier application number: M020
SPF Lip	TITANIUM DIOXIDE, ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359297cd-10e2-6ddd-e063-6394a90a4aa0	2025-12-12	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