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 264 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 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8a542b3c-c3c0-465a-9b24-6a62016656f3	2024-11-25	Warnings	Exact identifier application number: M020
CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	27c30645-dcef-bc31-e063-6394a90a1368	2024-11-25	Warnings	Exact identifier application number: M020
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15	OCTINOXATE AND TITANIUM DIOXIDE	Bobbi Brown Professional Cosmetics Inc.	b669c36d-4c94-455d-8534-9c3bb024d668	2024-11-25	Warnings	Exact identifier application number: M020
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15	VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15	Bobbi Brown Professional Cosmetics Inc.	eecb05ab-2048-6e8d-e053-2995a90a8280	2024-11-22	Warnings	Exact identifier application number: M020
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid Foundation	OCTINOXATE	Noxell Corporation	258e8f05-295e-8e32-e063-6294a90a7548	2024-11-21	Warnings	Exact identifier application number: M020
MILKY MINERAL SUN SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	53834c89-b3b4-4e21-b9f6-19f95e78ba83	2024-11-21	Warnings	Exact identifier application number: M020
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	5996f9b2-18c1-4c8f-a0ab-eca180db61ad	2024-11-21	Warnings	Exact identifier application number: M020
NATURAL MINERAL BODY SUNSCREEN	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	dc5116d4-3a42-44d4-b41a-e88b5b16d111	2024-11-21	Warnings	Exact identifier application number: M020
IMPECCABLE SKIN - IVORY	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	98a7896e-4b03-4184-ac2e-6b49e47c0bc4	2024-11-21	Warnings	Exact identifier application number: M020
1177, 1178 Sunscreen	1177, 1178 SUNSCREEN	Dynarex	c3142ddb-74ea-a7d1-e053-2a95a90a26f3	2024-11-20	Warnings	Exact identifier application number: M020
Covergirl Aquasmooth Broadspectrum SPF 20 All shades	TITANIUM DIOXIDE	Noxell Corporation	952ea869-581e-4503-9f21-a77d061a417d	2024-11-20	Warnings	Exact identifier application number: M020
Covergirl TruBlend Base Business Everyday Defense Primer SPF 20	ENSULIZOLE	NOXELL CORPORATION	8528aa01-fd4b-58a6-e053-2991aa0a3d6a	2024-11-20	Warnings	Exact identifier application number: M020
Facial Skin Shield Broad Spectrum SPF50 Plus	AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	bb62c700-be07-4fe3-b007-425a5f760b30	2024-11-20	Warnings	Exact identifier application number: M020
FOUNDATION LIGHT SPECTRUM	OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE	Guangzhou Bo win Trade Co., Ltd.	273ea785-241b-3e10-e063-6294a90a9fff	2024-11-19	Warnings	Exact identifier application number: M020
FOUNDATION MEDIUM SPECTRUM	OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE	Guangzhou Bo win Trade Co., Ltd.	273f4d65-b245-c27a-e063-6394a90ade07	2024-11-19	Warnings	Exact identifier application number: M020
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50	ZINC OXIDE	POOLBAR	c081acef-9e1d-4aa6-b49c-c92fe28af2c7	2024-11-19	Warnings	Exact identifier application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla Scented	ZINC OXIDE	POOLBAR	3a481521-e209-4c86-895f-2e7392b7c565	2024-11-19	Warnings	Exact identifier application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla Scented	ZINC OXIDE	POOLBAR	1721023c-3321-4f0b-a053-6d0c657fa1b0	2024-11-19	Warnings	Exact identifier application number: M020
Theraderm Platinum Protection Facial Sunscreen SPF 40	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Therapon Inc	1fea6ad8-4d33-4f7c-800c-1bee644bd97f	2024-11-19	Warnings	Exact identifier application number: M020
Fresh Monster Mineral Sunscreen	ZINC OXIDE	Blue Zebra Brands, Inc.	230cc36d-5163-f423-e063-6394a90a8124	2024-11-19	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