Broad Spectrum SPF 15 Coconut Lip Balm

Product NDC: 65692-0307
11-digit product format: 656920307
Labeler code: 65692
Product ID: 65692-0307_0decf6f7-de38-4584-8bfe-83596fb81e25
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: STICK
Route: TOPICAL
Labeler: Raining Rose, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-27
Substance: ZINC OXIDE
Active strength: 35 mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Broad Spectrum SPF 15 Coconut Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
2a03abc4-824b-438d-acc5-469853057679	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65692-0307-1	Broad Spectrum SPF 15 Coconut Lip Balm	4.25 g in 1 TUBE	STICK	4.25		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65692-0307	BROAD SPECTRUM SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [RAINING ROSE, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20231104_2a03abc4-824b-438d-acc5-469853057679.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 213 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melan Antioxidant Body Mist Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	MELAN INC.	f627b17f-d2dc-47bd-b865-08995995e861	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	63e078a3-d5df-4458-a745-e306d734e6be	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	90531e8f-15c6-49ac-96a4-3bdfab2bfd9b	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	28db9f44-780f-4cd5-940e-3ee779f38247	2025-05-20	Warnings	Exact identifier application number: M020
Mineral Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595149d-0735-6bea-e063-6394a90a618a	2025-05-20		Exact identifier application number: M020
Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595735e-c25f-eb48-e063-6294a90aac0f	2025-05-20		Exact identifier application number: M020
Coola Clear California Summers	OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE	COOLA, LLC	358009c4-492d-ac03-e063-6294a90af227	2025-05-19	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	ONESKIN INC.	3581f578-e19e-9ace-e063-6294a90acc34	2025-05-19	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	351251f5-e656-98b6-e063-6394a90ad805	2025-05-14	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	35129e6f-c6bd-a9f7-e063-6394a90ab0e4	2025-05-14	Warnings	Exact identifier application number: M020
Noevir Raysela UV Shield Primer	ZINC OXIDE, OCTINOXATE	Nippon Shikizai, Inc.	45030b2f-21cf-4285-af12-87ea8f0b8df7	2025-05-14	Warnings	Exact identifier application number: M020
OS-01 Lip SPF BS SPF15	ZINC OXIDE	ONESKIN INC.	351d55f6-fcd9-1d47-e063-6294a90a2cf0	2025-05-14	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350cd329-8fe2-314f-e063-6394a90ac954	2025-05-13	Warnings	Exact identifier application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30	ZINC OXIDE	Lancer Skincare LLC	522a9158-2fd1-4634-adef-2ba84c86bcd7	2025-05-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Navajo Manufacturing Company Inc.	33f13aa4-9279-c251-e063-6294a90a2d67	2025-05-12	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	Allure Labs	34f51ff4-541d-2b2e-e063-6394a90a39da	2025-05-12	Warnings	Exact identifier application number: M020
Bright Guard Natural SPF 30	ZINC OXIDE	Renu Laboratories, LLC	e7035fcd-6894-3360-e053-2a95a90a6f1d	2025-05-12	Warnings	Exact identifier application number: M020
Bright Guard Sport SPF	ZINC SPF	RENU LABORATORIES, LLC	c9b48a9e-d69f-65a7-e053-2995a90a0baf	2025-05-12	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	Allure Labs	34f674c1-5d59-915a-e063-6394a90a6c2f	2025-05-12	Warnings	Exact identifier application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE	Meaningful Beauty, LLC	f59fe019-569b-49ba-accf-fa4d356ce96b	2025-05-12	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65692-0307-1	65692030701	4.25 g in 1 TUBE (65692-0307-1)	4.25 g	2021-04-27	0000-00-00	No	No	Current