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 269 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banana Boat	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ce728be-966e-b662-e063-6394a90a0ba8	2024-10-30	Warnings	Exact identifier application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	COSMAX USA, INC.	2596a17e-4042-3544-e063-6294a90aa4c9	2024-10-29	Warnings	Exact identifier application number: M020
Sunblocz	ZINC OXIDE	Olen Skin Care Corporation	36fec1f1-5e8b-5764-e054-00144ff8d46c	2024-10-29	Warnings	Exact identifier application number: M020
Sunblocz Baby and Kids	ZINC OXIDE	Olen Skin Care Corporation	35cbb9d5-639c-207a-e054-00144ff88e88	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	fd7d40fe-178a-e1b1-e053-6294a90a29a1	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ZO Skin Health, Inc.	9a4f5be1-da04-48b9-897a-57f4a3d9d1ec	2024-10-29	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	e4a06973-21bb-4eda-9b74-fc23bee141ab	2024-10-29	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	36efd48b-910e-4b61-9519-a6d5c7e9a7c3	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Broad-Spectrum Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health, Inc.	d817f80b-a998-b67e-e053-2995a90a1971	2024-10-29	Warnings	Exact identifier application number: M020
SPF 15 Coconut Lip Balm	ZINC OXIDE	Naples Soap Company, Inc.	25a7510f-5ef3-9920-e063-6394a90a2079	2024-10-29	Warnings	Exact identifier application number: M020
Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	Bel Star S.A. (Colombia)	a7d69691-cecc-798e-e053-2a95a90a995f	2024-10-28	Warnings	Exact identifier application number: M020
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F	OCTINOXATE, ZINC OXIDE	Bel Star S.A.	eea17271-e8c8-ab21-e053-2995a90a2fcc	2024-10-28	Warnings	Exact identifier application number: M020
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR SA	fd90ffc6-a1e1-e02e-e053-6294a90a4e7c	2024-10-28	Warnings	Exact identifier application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	0b782198-58e7-5343-e063-6294a90a3713	2024-10-28	Warnings	Exact identifier application number: M020
FHF Elevated Shade 100% Mineral Sunscreen	SUNSCREEN	Owen Biosciences Inc	dabd3b95-01d3-014c-e053-2a95a90a0fec	2024-10-28	Warnings	Exact identifier application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BAY BELLE LABS	259653e7-dfe0-44a2-e063-6294a90a416d	2024-10-28	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8a21acbe-2f3d-cf78-e053-2a95a90a77f6	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	7961ff9f-75db-4977-e053-2a91aa0ae628	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8a1c9a3c-394e-9122-e053-2995a90acb23	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8b889b75-07ac-4276-e053-2a95a90a69c6	2024-10-27	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