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
IngredientStrength
ZINC OXIDE35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0307-1Broad Spectrum SPF 15 Coconut Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0307BROAD SPECTRUM SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [RAINING ROSE, INC.]2Current NDC, Legacy NDC, 1 package rows20231104_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 241 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Future Youth Daily Turnaround Hydrating Moisturizer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEPacifica Beauty, LLC0324275f-13bc-e7b8-e063-6294a90a69022025-01-03WarningsExact identifier
application number: M020
Glow Baby Super Lit SPF 30ZINC OXIDEPacifica Beauty, LLCf3d3eee2-a5d9-113b-e053-2995a90a70572025-01-03WarningsExact identifier
application number: M020
Kind Tint SPF 30ZINC OXIDEPacifica Beauty, LLCf421cbf7-cfae-5eae-e053-2995a90ab35c2025-01-03WarningsExact identifier
application number: M020
Vegan Collagen Every Day SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEPacifica Beauty, LLCf449da32-5ade-2c78-e053-2a95a90a27a12025-01-03WarningsExact identifier
application number: M020
Members Mark SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESam's West Inc2b354ab6-f241-676f-e063-6394a90a58932025-01-03WarningsExact identifier
application number: M020
Vanilla Mint Lip BalmLIP BALMCasad Company Inc.3214bff3-e133-43ca-946d-f4c5dd0747602025-01-03WarningsExact identifier
application number: M020
Vanilla Lip BalmLIP BALMCasad Company Inc.d27398d3-98b0-4f70-997e-6ed02559594f2025-01-03WarningsExact identifier
application number: M020
Cherry Lip BalmLIP BALMCasad Company Inc.b262645e-f069-420d-90ac-9eb4b82236d82025-01-03WarningsExact identifier
application number: M020
Peppermint Lip BalmLIP BALMCasad Company Inc.46a4b6d1-37e4-471d-a41b-57afe8bd9f2f2025-01-03WarningsExact identifier
application number: M020
Beeswax Lip BalmLIP BALMCasad Company Inc.5301398d-82f8-495e-b3ec-0938eca163692025-01-03WarningsExact identifier
application number: M020
Spearmint Lip BalmLIP BALMCasad Company Inc.ba9b5420-60b0-4528-9898-a0a5287a2aee2025-01-03WarningsExact identifier
application number: M020
Pomegranate Lip BalmLIP BALMCasad Company Inc.4e943a8a-f627-4e28-bdd7-c2b63be5dca32025-01-03WarningsExact identifier
application number: M020
Tropical Lip BalmLIP BALMCasad Company Inc.5e730d21-b810-4b84-9c85-0343ab0c8d5a2025-01-03WarningsExact identifier
application number: M020
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 BambooZINC OXIDEEVER FAME PTE. LTD.2abbc7fb-ea5d-9c68-e063-6394a90a88d22025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 AlmondZINC OXIDEEVER FAME PTE. LTD.2abbd076-825d-df76-e063-6294a90a22fc2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ButterZINC OXIDEEVER FAME PTE. LTD.2abbf4a1-a404-b36c-e063-6394a90a41a82025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ButterscotchZINC OXIDEEVER FAME PTE. LTD.2abc0d57-cf8b-2508-e063-6294a90a8ee02025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CappuchinoZINC OXIDEEVER FAME PTE. LTD.2abc72f5-d1fd-c4f4-e063-6394a90aab9a2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CamelZINC OXIDEEVER FAME PTE. LTD.2abc3ffb-ce18-6a64-e063-6294a90a8ab12025-01-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65692-0307-1656920307014.25 g in 1 TUBE (65692-0307-1) 4.25 g2021-04-270000-00-00NoNoCurrent