FDA.reportPublic FDA data

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

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 1 of 360 · 7,197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
HERA UV PROTECTOR INVISIBLE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOTCM584c371c-24e3-5f9c-e063-6294a90a01bc2026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact 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