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 74 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROTEKT SPF-50 Sheer Mineral Sunscreen	ZINC OXIDE	Protekt Products, Inc.	6edc0941-bb21-4797-a875-81f727694774	2026-01-19	Warnings	Exact identifier application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)	ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%	Grace and Fire USA Inc.	48c1b93c-9c6f-95aa-e063-6294a90a0cfa	2026-01-19	Warnings	Exact identifier application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	446ac344-1078-4cd1-e063-6294a90a4bd4	2026-01-19	Warnings	Exact identifier application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	31af7b5e-2bd6-63ee-e063-6294a90a0806	2026-01-19	Warnings	Exact identifier application number: M020
ANUA INVISIBLE MATTE FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	4248deaf-ad55-a9b4-e063-6294a90a55cc	2026-01-19	Warnings	Exact identifier application number: M020
ONSART Mineral Sunscreen	ZINC OXIDE 24%	Guangzhou Huixue Biotechnology Co., Ltd.	48c9d08d-9a91-7df5-e063-6294a90a1c4a	2026-01-19	Warnings	Exact identifier application number: M020
Intense Moisture Day Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	CVS Health	795d3546-f0dd-4b54-9807-9cdb3e626181	2026-01-19	Warnings	Exact identifier application number: M020
CURESHIELD MANICURE SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	48b4fad7-073d-d983-e063-6394a90ae314	2026-01-18	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	65ff0448-17e6-42ce-989a-940794fcbd8c	2026-01-17	Warnings	Exact identifier application number: M020
BenzoAzeline 10	BENZOYL PEROXIDE	Noon Aesthetics M.R. Ltd	985efa19-bd91-45cd-a2a0-d71ec325e51c	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Berry SPF 30	PREQUEL LIP VISOR BERRY SPF 30	The Center Brands, LLC	e4f3a0eb-4a8c-4145-92e4-979f03e3a511	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Blush SPF 30	PREQUEL LIP VISOR BLUSH SPF 30	The Center Brands, LLC	bc681245-e158-4cfa-9718-7ec4cff0e60d	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Mahogany SPF 30	PREQUEL LIP VISOR MAHOGANY SPF 30	The Center Brands, LLC	ea8dcd14-3c54-46a6-aabc-3655f051065b	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Nude SPF 30	PREQUEL LIP VISOR NUDE SPF 30	The Center Brands, LLC	03a7c77d-7b6e-4720-88f1-492ce57c7145	2026-01-16	Warnings	Exact identifier application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30	ZINC OXIDE	CVL Cosmetics North America Inc	f3057856-1461-41d3-a5c4-9f12e3a4a0ee	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	04e9c4d8-1600-4ffc-8578-4ffb82b106f3	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1aae19da-1e73-41ed-91dc-0746ad311b87	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	22d4452d-3798-48c6-a7a4-4af0f99b4ebd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d6800bb7-16ef-48f6-a09a-0422e64ad8bd	2026-01-16	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