FDA.reportPublic FDA data

Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra Lotion SPF 50

Manufacturer
FRUIT OF THE EARTH, INC.
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:37

Label at a glance#

ProductFruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: Ask a doctor • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher an...

Storage and handling

• protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics/materials or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 7.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: Ask a doctor

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other information

STORAGE AND HANDLING SECTION

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics/materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexyl glycerin, sorbitan isostearate, benzyl alcohol, fragrance

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LS58805ALS58805A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-404-25Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50177 mL in 1 TUBELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-404FRUIT OF THE EARTH LUV THAT SUN SPORT SUNSCREEN ULTRA SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [FRUIT OF THE EARTH, INC.]2Current NDC, 1 package rows20241020_fd687b34-e4c6-0458-e053-6394a90ac064.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-40462217-404-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
SORBITOL506T60A25RIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
POLYETHYLOXAZOLINE (200000 MW)I765I75FT2IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
BENZYL ALCOHOLLKG8494WBHIACT
TROLAMINE9O3K93S3TKIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd687b34-e4c6-0458-e053-6394a90ac0642024-10-18WarningsExact identifier
ndc (package): 62217-404-25
ndc (product): 62217-404
ndc11 (package): 62217040425
spl id: 24c8180d-d018-6aee-e063-6394a90a7ae0
spl set id: fd687b34-e4c6-0458-e053-6394a90ac064

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.