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 44 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
application number: M020
MIDHA Rice Daily Moisture Sun CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMIDHA Cosmetic Co.,Ltd.4b394107-7830-c2c6-e063-6294a90a07d92026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube DeepOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f15d5ba-6396-56bf-e063-6394a90adb062026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube LightOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f165895-aa84-e215-e063-6394a90a62562026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube MediumOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f16b8a4-4279-5f79-e063-6294a90a353d2026-04-10WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf5ca0416-548c-4be0-a69e-c7e1b52aba952026-04-10Warnings, Adverse reactionsExact identifier
application number: M020
LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHTZINC OXIDEThe Green Cricket Incc56fd135-f46a-51ce-e053-2a95a90ab7b32026-04-10WarningsExact identifier
application number: M020
CorTex SunX 50 ThickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Incf67a6c6c-c314-1c9d-e053-2a95a90a7f1a2026-04-10WarningsExact identifier
application number: M020
Nu Skin 180 Degree UV Block Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc.b9635e59-bb08-4167-b7ba-54c3fc7125892026-04-09WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.79c6fe2a-34c2-44cc-81bc-796c4463d2a62026-04-09Warnings, Adverse reactionsExact identifier
application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fdbae5-84ec-7b1d-e063-6294a90a28782026-04-09WarningsExact identifier
application number: M020
Arizona Sun Prickly Pear Lip Balm SPF 15SUNSCREEN LIP BALMArizona Sun Products11e9cb25-6ff8-a121-e063-6394a90a849e2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 8SUNSCREENArizona Sun Products11e8b612-29be-47ed-e063-6394a90ab9e72026-04-09WarningsExact identifier
application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fdcfd0-8b24-7efc-e063-6294a90af7fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Cycleblok SunscreenSUNSCREENArizona Sun Products11e71a84-12d1-2d4f-e063-6294a90adcd62026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Bikerblok SunscreenSUNSCREENArizona Sun Products11e6eafd-f967-b748-e063-6394a90aabfd2026-04-09WarningsExact identifier
application number: M020
YSE Beauty Skin Glow Primer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6a318e27-14e5-488e-ac19-010f69cb743d2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30SUNSCREENArizona Sun Products116ed17c-3b38-5e96-e063-6294a90a42462026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Surfblok SunscreenSUNSCREENArizona Sun Products11e76815-9316-555d-e063-6294a90aeb812026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products1171af26-3040-552c-e063-6294a90ae2202026-04-09WarningsExact 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