FDA.reportPublic FDA data

Fruit of the Earth

Product NDC
62217-316
11-digit product format
622170316
Labeler code
62217
Product ID
62217-316_24c7dec2-2de6-6b27-e063-6394a90a1473
Type
HUMAN OTC DRUG
Nonproprietary name
Lip Balm SPF 30 Sunscreen Stick
Dosage form
STICK
Route
TOPICAL
Labeler
Fruit of the Earth, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-13
Substance
OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Active strength
50; 50; 30; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Fruit of the Earth
Brand name suffix
Sun Town City
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/g
OCTOCRYLENE50 mg/g
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ec16996-ae86-4f5b-b1fd-c7b509cc5d50Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62217-316-592021-07-23C16284748780-1c7ccaba7-282c-fd44-e053-dadaa90aa01bFruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick
62217-316-852021-07-23C16284748780-1c7ccaba7-282c-fd44-e053-dadaa90aa01bFruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-316-58Fruit of the EarthSun Town City4.25 g in 1 CONTAINERSTICK4.253
62217-316-59Fruit of the EarthSun Town City1 in 1 BLISTER PACKSTICK13
62217-316-84Fruit of the EarthSun Town City17 g in 1 CONTAINERSTICK173
62217-316-85Fruit of the EarthSun Town City1 in 1 BLISTER PACKSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-316FRUIT OF THE EARTH SUN TOWN CITY (LIP BALM SPF 30 SUNSCREEN STICK) STICK [FRUIT OF THE EARTH, INC.]3Current NDC, Legacy NDC, 4 package rows20241020_3ec16996-ae86-4f5b-b1fd-c7b509cc5d50.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 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENETrilipid Research Institute, LLC7f34de0a-eeb3-4b71-9abd-53d03266d9932026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6a43173f-41f9-4207-a0db-53bc8db6f4a42026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd69b4992-d7e6-4bd7-b144-0485e35818a62026-09-10WarningsExact identifier
application number: M020
Hydra Finish SPF 15HOMOSALATE, OCTINOXATEGuinot4047e8ec-834a-41e6-a144-5649a7718de42026-09-10WarningsExact identifier
application number: M020
HYDRA BEAUTE SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot806d1e18-a3fc-43df-a52a-a640902d08872026-09-10WarningsExact identifier
application number: M020
Pur Confort SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot2fe0656f-f924-48da-91bf-d6f3d98e8fd92026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinotb0a95379-998a-4cda-bae7-63faf3d6f3c82026-09-10WarningsExact identifier
application number: M020
Sun Logic Lait Solaire Corps SPF 20AVOBENZONE, HOMOSALATE, OCTOCRYLENEGuinotd9d2cee0-9189-42d0-b1ab-78b97141b1282026-09-10WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 301226 W AESTHETICS5b0ef395-a7dd-378e-e063-6394a90a5dce2026-09-09WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
application number: M020
Baloom 2% Panthenol Hydro Airy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENEARSN KOREA5148b638-f8a4-fa8b-e063-6294a90ac2082026-09-08WarningsExact identifier
application number: M020
Double-Duty Face MoisturizerMOSITURIZING SUNSCREENJack Black, LLC672be406-e3a1-47b4-8ef6-ee2b62baae962026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62217-316-58622170316584.25 g in 1 CONTAINER4.25 gHistorical
62217-316-59622170316591 CONTAINER in 1 BLISTER PACK (62217-316-59) / 4.25 g in 1 CONTAINER (62217-316-58) 1 container2020-02-130000-00-00NoNoCurrent
62217-316-846221703168417 g in 1 CONTAINER17 gHistorical
62217-316-85622170316851 CONTAINER in 1 BLISTER PACK (62217-316-85) / 17 g in 1 CONTAINER (62217-316-84) 1 container2020-02-130000-00-00NoNoCurrent