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 133 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenishing Daily ProtectionZINC OXIDEThe Maui Medical Group, Inc34b96d82-7fcf-e452-e063-6394a90a781b2025-12-11Exact identifier
application number: M020
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC3750ffbf-a82d-b4b9-e063-6294a90a7d682025-12-11Exact identifier
application number: M020
The BlockZINC OXIDEELITE ESTHETICS BY NICOLE CAROLINE LLC34a6b17e-6e9e-3f2c-e063-6294a90a1c322025-12-11Exact identifier
application number: M020
SPF 40 Broad Spectrum Non-TintedZINC OXIDETeton Dermatology Holdings, Inc.35093797-008b-b265-e063-6294a90a99492025-12-11Exact identifier
application number: M020
Tinted Zinc ProtectionZINC OXIDETeton Dermatology Holdings, Inc.3508d5a8-9d3c-51d1-e063-6394a90abc8e2025-12-11Exact identifier
application number: M020
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
application number: M020
Antioxidant SPFZINC OXIDETeton Dermatology Holdings, Inc.3509a916-f3e1-9c53-e063-6394a90a5bff2025-12-11Exact identifier
application number: M020
Ultimate Physical Sunscreen TintedZINC OXIDEHALEM DERMATOLOGY PLLC35bb4953-ca8c-e927-e063-6394a90a1a312025-12-11Exact identifier
application number: M020
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact identifier
application number: M020
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35bc5ff5-8eb8-54cf-e063-6394a90ae3c22025-12-11Exact identifier
application number: M020
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350ad191-e51c-083d-e063-6394a90aa6462025-12-11Exact identifier
application number: M020
Ultimate Physical SunscreenZINC OXIDEHALEM DERMATOLOGY PLLC35be5dc0-861f-3738-e063-6394a90a23ca2025-12-11Exact identifier
application number: M020
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350b2246-6e00-38fc-e063-6294a90ae3822025-12-11Exact identifier
application number: M020
Calming Protection SPF40ZINC OXIDEFRESH FACED SKIN CARE LLC35d0c081-67b4-ce46-e063-6294a90ad8222025-12-11Exact identifier
application number: M020
Tinted Facial Protection SPF40TITANIUM DIOXIDE, ZINC OXIDEFRESH FACED SKIN CARE LLC35d08e2a-b118-8634-e063-6294a90a918d2025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDETHE COMPLEXIONIST38f53f6a-8e68-e30f-e063-6394a90afef22025-12-11Exact identifier
application number: M020
Fair Skin Anti-AgingZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351bb329-90ea-f19a-e063-6394a90af1072025-12-11Exact identifier
application number: M020
Oil Free Anti-AgingZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351b4870-d9bd-c356-e063-6394a90a77632025-12-11Exact 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