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 154 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35	AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE	CLINIQUE LABORATORIES LLC	44fe7468-001c-f2ee-e063-6394a90ae3b4	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Super Leaves Lip Balm SPF15 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff1fc0-9ac5-2c9a-e063-6294a90a4632	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Coconut	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff5675-fd8d-b665-e063-6294a90a1e0b	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Pineapple	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ffb35b-80f4-7ddb-e063-6394a90a2cbb	2025-12-02	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	44ffd469-0205-846f-e063-6294a90af6b5	2025-12-02	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	daf0291e-770c-eaf2-e053-2a95a90a0b67	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Dewy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE	70541	44e0098c-170f-ca51-e063-6294a90aed20	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Sun Essence	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e194cd-ea61-71b3-e063-6394a90ac486	2025-12-01	Warnings	Exact identifier application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50	ZINC OXIDE	Venture Performance Inc	630fc5c2-a315-4e26-9bd9-5f8533d75908	2025-12-01	Warnings	Exact identifier application number: M020
EMINENCE Red Currant Protective Moisturizer	OCTINOXATE, ZINC OXIDE	Eminence Organic Skin Care	7eca62af-6f70-44ec-879e-74712163c4e0	2025-12-01	Warnings	Exact identifier application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer	AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE	Charlotte Tilbury Beauty Ltd.	2b215ecb-7c3a-63db-e063-6394a90aa88f	2025-12-01	Warnings	Exact identifier application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	LIFE WITHCORPORATION Inc.	44ea9fb4-8e01-6969-e063-6294a90a6a94	2025-12-01	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENE	Roc Skincare	2b3656d6-4b3a-9ef2-e063-6294a90acaa6	2025-12-01	Warnings	Exact identifier application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Rare Beauty Brands Inc.	44ec0db5-4437-e4a3-e063-6294a90a9a00	2025-12-01	Warnings	Exact identifier application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RoC Skincare	2888a198-116b-8441-e063-6394a90a0f95	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Very High Sun Protection sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ec619f-ed3b-2fd3-e063-6294a90a858b	2025-12-01	Warnings	Exact identifier application number: M020
Reef safe - Face and Body sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38603298-e8da-e4c7-e063-6394a90aca3b	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44dd513e-ebaa-0d6a-e063-6394a90a78b7	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc0ae-a977-3adf-e063-6294a90a0898	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc4d8-3f3b-5d11-e063-6294a90ae88a	2025-11-30	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