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 267 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f5a006d1-e957-4063-9b45-2874a1445a33	2024-11-11	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6943a531-c4e7-4e98-9970-3a30b9681b7b	2024-11-11	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a74102d3-b535-4419-8e21-e961980e489d	2024-11-11	Warnings	Exact identifier application number: M020
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50	TITANIUM DIOXIDE AND ZINC OXIDE	DARPHIN DIST.	91277514-4db0-4b40-b95a-3530cac711df	2024-11-11	Warnings	Exact identifier application number: M020
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Aveda Corporation	dfa84bcc-a9b4-426d-8733-35f58c40e94d	2024-11-11	Warnings	Exact identifier application number: M020
SPF30 SUPER SENSITIVE SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	fef47045-1d3c-4f08-acec-e96abefbc261	2024-11-08	Warnings	Exact identifier application number: M020
Mele	NO SHADE SUNSCREEN OIL	CONOPCO Inc. d/b/a Unilever	bd969eab-1da6-76a8-e053-2995a90a5c47	2024-11-07	Warnings	Exact identifier application number: M020
Vaseline Men plus Care Hydrate Face	AGING CHEST AND NECK RESCUE TREATMENT CREAM	CONOPCO Inc. d/b/a Unilever	bd0a9f3c-eaa9-47d0-e053-2995a90ab617	2024-11-07	Warnings	Exact identifier application number: M020
Vaseline	AGING CHEST AND NECK RESCUE TREATMENT CREAM	CONOPCO Inc. d/b/a Unilever	bd965bbc-c9d1-c8da-e053-2995a90a2258	2024-11-07	Warnings	Exact identifier application number: M020
St. Ives Men plus Care Hydrate Face	SOLUTIONS CLEAR SKIN MOISTURIZER SUNSCREEN	CONOPCO Inc. d/b/a Unilever	bcbaaa15-479d-b130-e053-2a95a90afa3b	2024-11-07	Warnings	Exact identifier application number: M020
Dove Men plus Care Hydrate Face	AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE	CONOPCO Inc. d/b/a Unilever	5c28d679-3f92-49e3-8bef-de1c3870f009	2024-11-07	Warnings	Exact identifier application number: M020
Mele Men plus Care Hydrate Face	NO SHADE SUNSCREEN OIL	CONOPCO Inc. d/b/a Unilever	bb2921bc-8892-1db2-e053-2995a90ae28c	2024-11-07	Warnings	Exact identifier application number: M020
Ponds	REJUVENESS ANTI-WRINKLE DAILY MOISTURIZER WITH SUNSCREEN SPF 30	CONOPCO Inc. d/b/a Unilever	736ee790-99f7-686c-e053-2a91aa0ad16e	2024-11-07	Warnings	Exact identifier application number: M020
Mele Men plus Care Hydrate Face	DEW THE MOST SHEER MOISTURIZER SUNSCREEN	CONOPCO Inc. d/b/a Unilever	bb27185b-5732-a648-e053-2a95a90aa930	2024-11-07	Warnings	Exact identifier application number: M020
Ponds	CLARANT B3 EVEN SKIN TONE DAILY MOISTURIZER WITH SUNSCREEN SPF 30	CONOPCO Inc. d/b/a Unilever	736ee790-9a15-686c-e053-2a91aa0ad16e	2024-11-07	Warnings	Exact identifier application number: M020
Byoma Ultralight Face Fluid SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BYOMA LIMITED	2657bca4-bdc7-d959-e063-6394a90a2aa1	2024-11-07	Warnings	Exact identifier application number: M020
Byoma Ultralight Face Fluid SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BYOMA LIMITED	2658df86-8cbb-83dd-e063-6394a90ac4e8	2024-11-07	Warnings	Exact identifier application number: M020
SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	547388c6-378b-488b-89d1-c77ebc5d2ed8	2024-11-07	Warnings	Exact identifier application number: M020
SPF30 SUMMER BLEND SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	9641b71a-81f2-4157-801b-162188392a91	2024-11-07	Warnings	Exact identifier application number: M020
SPF30 SUPER SENSITIVE SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	d79cf2d9-4923-452a-bb44-67e059ee37ee	2024-11-07	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