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 309 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	f296e5ef-728a-4d57-8d65-7d88b1f90f88	2023-12-31	Warnings	Exact identifier application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide Mineral	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	bcf5e724-b40a-49dd-8a09-57cefd7f65ad	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Correct Broad Spectrum SPF 70 Daily Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	a7c01228-02db-49a8-bb91-cee13fbd1df1	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	202d8dda-b425-498f-aa82-1470c0cf0c23	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	e72ae48f-e4ec-458b-ae2b-bd6cb98552f9	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Pigmentclar Daily Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	197ea8bf-0d84-42cb-bf29-087ad9587877	2023-12-31	Warnings	Exact identifier application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE	L'Oreal USA Products, Inc.	2138f86b-3937-4c2b-9568-d40a745b637d	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	533e6623-108e-4d05-8527-c5af643f0800	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense 24 Hour Hydrating Moisturizer Broad Spectrum SPF 20 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	2f90f046-080b-4033-97b0-245fcc0f3683	2023-12-31	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	L'Oreal USA Products Inc	27d82e37-67ac-4cd3-83c0-fb8388d3a0dd	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	d7bf3928-85b8-4e5f-a04a-d520130a3340	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	dc1a1b9f-fcc1-45bc-89e7-169bf240663d	2023-12-31	Warnings	Exact identifier application number: M020
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	8e94e203-d3cf-45a1-88f9-6999f0aab22b	2023-12-31	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	30cb2f12-1ebe-4850-be16-17748f0ba670	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	74ea4031-bb23-4028-ae32-78213646f66c	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Facial Fuel Daily Energizing Moisture Treatment for Men Broad Spectrum SPF 20 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	dd6134f8-e2e0-49bf-bfec-ab04bfa5678b	2023-12-30	Warnings	Exact identifier application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3d9ed59f-f280-4cc2-a0f1-4180deb5b792	2023-12-30	Warnings	Exact identifier application number: M020
IT Cosmetics Your Skin But Better CC Plus Nude Glow Color Correcting Medium Coverage Skin Tint Brightening Glow Serum Broad Spectrum SPF 40 Sunscreen All Shades	HOMOSALATE, OCTISALATE AND OCTOCRYLENE	IT COSMETICS, LLC	2bdc6c73-d3e7-4a23-89dd-e4ffe44c034b	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	02c51b56-e39a-4b3b-88c6-b7dc9c165f7e	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	eb43177e-389d-4572-8521-ee4d0a2dad3a	2023-12-30	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