FDA.reportPublic FDA data

Body Butter Broad Spectrum Sunscreen SPF 40

Manufacturer
Taylor James Ltd.
Effective date
2021-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:42

Label at a glance#

ProductBody Butter Broad Spectrum Sunscreen SPF 40
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients  Purpose

Avobenzone 3%     Sunscreen

Octisalate 5%         Suncreen

Octocrylene 10%    Sunscreen

OTC - PURPOSE SECTION

Uses

• Helps Prevent Sunburn
• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
If swallowed, get medical help or contact a poison Control Center right away

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Isododecane, Glycerin, Trimethoxybenzylidene Pentanedione, Polyester-8, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Oryza Sativa (Rice) Bran Extract, Sucrose Stearate, Diisopropyl Sebacate, Hydroxyacetophenone, Isodecyl Neopentanoate, Lauryl Lactate, Sodium Polyacrylate Starch, Diethylhexyl Syringlidenemalonate, Sodium Stearoyl Glutamate, C18-38 Alkyl Hydroxystearoyl Stearate, Chlorphenesin, Ethylhexylglycerin, 1,2 Hexanediol, Caprylyl Glycol, Helianthus Annuus(Sunflower) Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Tocopherol, Romarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Hippophae Rhamnoides Seed Oil, Citrus Nobilis (Manadarin Orange) Peel Oil, Cymbopogon Schoenanthus Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Supergoop!

Body Butter

SPF 40

Broad Spectrum Sunscreen SPF 40

5.7 fl. oz./168 ml

Body Butter 5.7Body Butter 5.7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-256-012023-01-30C16284748780-1f386c64a-2b2b-0266-e053-dadaa90a7c1aBody Butter SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-256-01Body Butter Broad Spectrum Sunscreen SPF 40168 mL in 1 PACKAGECREAM1682

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-256BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [TAYLOR JAMES LTD.]2Legacy NDC, 1 package rows20211012_ab5db9ba-3ecb-4cf1-84bb-d1dcde8647f3.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-25675936-256-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
TRIMETHOXYBENZYLIDENE PENTANEDIONE322V0ACF25IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN OLIVATEMDL271E3GRIACT
RICE BRANR60QEP13ICIACT
SUCROSE STEARATE274KW0O50MIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
LAURYL LACTATEG5SU0BFK7OIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CHLORPHENESINI670DAL4SZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
ROSEMARYIJ67X351P9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
MANDARIN OILNJO720F72RIACT
CYMBOPOGON SCHOENANTHUS OILXE7K568ILOIACT
CARDAMOM OILJM0KJ091HZIACT
CLOVE LEAF OILVCA5491KVFIACT
CHINESE CINNAMON LEAF OIL4U4V2F2E4YIACT
VANILLINCHI530446XIACT
EUCALYPTUS OIL2R04ONI662IACT
LAVANDIN OIL9RES347CKGIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML · Source PDF

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
ce1ad06e-6d67-7557-e053-2995a90aa0c9ab5db9ba-3ecb-4cf1-84bb-d1dcde8647f32021-10-11WarningsExact identifier
spl id: ce1ad06e-6d67-7557-e053-2995a90aa0c9
spl set id: ab5db9ba-3ecb-4cf1-84bb-d1dcde8647f3

Reported adverse events (FAERS/openFDA)#

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