FDA.reportPublic FDA data

enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30

Product NDC
59899-007
11-digit product format
598990007
Labeler code
59899
Product ID
59899-007_0949a165-7664-8fc6-e063-6294a90a9cb3
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Shaklee Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-11
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
50; 30; 100; 100 mg/mL; mg/mL; mg/mL; mg/mL
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
enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE100 mg/mL
HOMOSALATE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal 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
c57bfab7-f67c-435b-8703-e2051cfd097eAvailable on FDA.report

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
HOMOSALATEACTIVE INGREDIENTV06SV4M95SENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
OCTISALATEACTIVE INGREDIENT4X49Y0596WENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
AVOBENZONEACTIVE MOIETYG63QQF2NOXENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
HOMOSALATEACTIVE MOIETYV06SV4M95SENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
OCTISALATEACTIVE MOIETY4X49Y0596WENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
Magnesium Ascorbyl PhosphateINACTIVE INGREDIENT0R822556M5ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXAENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4
waterINACTIVE INGREDIENT059QF0KO0RENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [SHAKLEE CORPORATION]4

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

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 236 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bondi Sands SPF 60 Sunny Spritz Body MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0fe721-b92a-4181-e063-6394a90a846a2025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut CrushAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b142875-d413-aebe-e063-6394a90aaca02025-01-06WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil Free SPF 40GLO SKIN BEAUTY OIL FREE SPF 40Hayden Caleel LLC6b27a508-8669-418f-bcb2-61a35b79a3a82025-01-05WarningsExact identifier
application number: M020
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
application number: M020
glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30Hayden Caleel LLC9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d2025-01-05WarningsExact identifier
application number: M020
Wildberry Lip BalmLIP BALMCasad Company Inc.5e13dc33-67b7-4461-bec5-0c3edc72f8b42025-01-03WarningsExact identifier
application number: M020
Iced Pear Lip BalmLIP BALMCasad Company Inc.1d9a62dd-c11e-4f97-9164-edc84adbe05b2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandalwoodZINC OXIDEEVER FAME PTE. LTD.2ace641a-b440-d0b3-e063-6394a90a86322025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SepiaZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e82d-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 TruffleZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e830-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WalnutZINC OXIDEEVER FAME PTE. LTD.2acf75d2-8ad7-1bd3-e063-6294a90ac0be2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WheatZINC OXIDEEVER FAME PTE. LTD.2acf92a1-6d2a-5517-e063-6294a90a74882025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Warm VanillaZINC OXIDEEVER FAME PTE. LTD.2acf9020-c779-31c2-e063-6294a90a1ab52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad009bc-29ce-0ba6-e063-6294a90a75802025-01-03WarningsExact identifier
application number: M020
Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad07286-f8af-7a9f-e063-6394a90a6a242025-01-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59899-007-01598990007011 TUBE in 1 CARTON (59899-007-01) / 118 mL in 1 TUBE1 tube2013-11-110000-00-00NoNoCurrent