FDA.reportPublic FDA data

enfuselle BODY LOTION SUNSCREEN BROAD SPECTRUM SPF 30

Manufacturer
Shaklee Corporation
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:58:48

Label at a glance#

Productenfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure11 sections

Indications and uses

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

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

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10% Octocrylene 10% Octisalate 5% Avobenzone 3%


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on damaged or broken skin Do not use

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove When using this product

OTC - STOP USE SECTION

if rash occurs Stop use and ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
  • children under 6 months: Ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Microcrystalline Wax, Cetyl Dimethicone, Cyclohexasiloxane, Panthenol, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Beta-Glucan, Retinyl Palmitate, Vitis Vinifera (Grape) Seed Extract, Superoxide Dismutase, Glycerin, Hydrogenated Castor Oil, Ethylhexylglycerin, Phenyl Trimethicone, Caprylyl Glycol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Sodium Chloride, Silica, Disodium EDTA, Phenoxyethanol














Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

925.734.3638

PRINCIPAL DISPLAY PANEL CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WATER RESISTANT

PARABEN FREE

4 fl. oz. 118 mL

              All Skin Types Multipatented formula provides broad-spectrum SPF 30 protection from sun’s harmful rays to help reduce the risk of skin damage. Regular use of this product may help minimize visible lines, uneven coloration, dryness, and dullness associated with sun exposure. Triple patented Vital Repair+ Complex® helps disarm free radicals, which can create prematurely older-looking skin. Quickly absorbed lotion locks in moisture without leaving a sticky finish. Ideal for sensitive skin.













• Contains triple patented Vital Repair+ Complex® • Water resistant (80 minutes) • Designed not to clog pores • 100% fragrance and paraben free • Allergy tested • Clinically formulated • Dermatologist tested • Patented sensitive-skin formula • Not tested on animals










Dist. by/par Shaklee Corporation 4747 Willow Road Pleasanton, CA 94588 USA Item #32565 Imp. by/par Shaklee Canada Inc. 3100 Harvester Road, Unit 7 Burlington, ON L7N 3W8





CARTONCARTON

PRINCIPAL DISPLAY PANEL TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broad-spectrum SPF 30 protection helps shield skin from sun’s harmful rays. 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.


Directions: Apply generously 15 minutes before sun exposure.

TUBETUBE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59899-007-01enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 301 in 1 CARTONLOTION110
59899-007-01enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30118 mL in 1 TUBELOTION11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59899-007ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]10Current NDC, Legacy NDC, 2 package rows20231104_c57bfab7-f67c-435b-8703-e2051cfd097e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX4
HOMOSALATEACTIVE INGREDIENTV06SV4M95S4
OCTISALATEACTIVE INGREDIENT4X49Y0596W4
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM4
AVOBENZONEACTIVE MOIETYG63QQF2NOX4
HOMOSALATEACTIVE MOIETYV06SV4M95S4
OCTISALATEACTIVE MOIETY4X49Y0596W4
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ4
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D34
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P4
GlycerinINACTIVE INGREDIENTPDC6A3C0OX4
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01Q4
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY4
Magnesium Ascorbyl PhosphateINACTIVE INGREDIENT0R822556M54
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY4
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R4
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S74
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC4
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA4
waterINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59899-00759899-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 50THT5PCI0RIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
SODIUM CHLORIDE451W47IQ8XIACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
6 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
6 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
6 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii+route
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates

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
enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEShaklee Corporationc57bfab7-f67c-435b-8703-e2051cfd097e2023-11-03WarningsExact identifier
ndc (package): 59899-007-01
ndc (product): 59899-007
ndc11 (package): 59899000701
spl id: 0949a165-7664-8fc6-e063-6294a90a9cb3
spl set id: c57bfab7-f67c-435b-8703-e2051cfd097e

Reported adverse events (FAERS/openFDA)#

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