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 255 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips PearlOCTINOXATE, OCTISALATEThe Mentholatum Company43e175b4-7a48-431e-bf27-9ce7dee53f5e2024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
application number: M020
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact 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