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 73 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922e001-e699-7ac5-e063-6394a90a25d9	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	a9350360-7932-459f-806c-399fa265e6c0	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1923067f-1ab9-d168-e063-6394a90adbd0	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922ee84-d7d0-80b1-e063-6394a90acf7b	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	310a07bb-d32a-401f-955e-4c2860148a30	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	39ae4a97-7f96-4c95-a6de-0c779764fb02	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922fc3e-055c-e51d-e063-6294a90a00f5	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	9c7a31df-5bdd-403b-b807-1d1a801e1bb6	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922fc51-ae53-acb8-e063-6394a90a14eb	2026-01-20	Warnings	Exact identifier application number: M020
Wrinkle Repair Moisturizer SPF 30 EQB	AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%	Walmart	a067e968-e598-40ef-95f2-c338b5e413dd	2026-01-20	Warnings	Exact identifier application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Welmedix LLC	48da4589-0f5a-c25b-e063-6394a90ac18b	2026-01-20	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen Kids	ZINC OXIDE 14.69%	S&C Hampton Sun LLC	0bdb7d15-dc52-4e23-9417-fe73f17f6110	2026-01-20	Warnings	Exact identifier application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK	OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE	DEWYTREE CO. ,LTD	48406e68-eefd-d2c2-e063-6394a90a4ad9	2026-01-20	Warnings	Exact identifier application number: M020
KONEUK SUNSCREEN SPF50	KONEUK SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	48dd7f6e-2a4d-2c92-e063-6294a90a4255	2026-01-20	Warnings	Exact identifier application number: M020
CHUDA	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	Premier Ocher LLC	1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f	2026-01-20	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	12edec55-2414-4bbd-bc96-4599a96b96ac	2026-01-19	Warnings	Exact identifier application number: M020
PROJECT REEF SPF-30 Mineral Sunscreen	ZINC OXIDE	Project Reef LLC	a6077e6f-d987-4159-946f-3e2397247659	2026-01-19	Warnings	Exact identifier application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	86ee2fdf-8a88-44e6-b12a-36a92360477a	2026-01-19	Warnings	Exact identifier application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30	ZINC OXIDE	SABAL SUN LLC	f917b446-4e10-4231-826e-fdac32e11186	2026-01-19	Warnings	Exact identifier application number: M020
Plius Daily SPF Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	PLIUS, Inc	31866de9-afa0-4c11-be65-b61373551493	2026-01-19	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