FDA.reportPublic FDA data

GET MR. Butter Body Spray SPF-30

Manufacturer
Biomin LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:21:05

Label at a glance#

ProductGET MR. Butter Body SPF-30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (6.0%)

Zinc Oxide (6.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash or irritation occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying. At least every 2 hours.

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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm. Wear long sleeve shirts, pants, hats and sunglasses. For children under 6 months: consult a physician. Sun Protection Measures:

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric  Triglyceride, Caprylyl/Capryl Glucoside, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Extract, Gluconolactone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum.

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Questions?:

OTC - QUESTIONS SECTION

+1 866 438 6712

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82177-20382177-203-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
WATERMELON231473QB6RIACT
DAUCUS CAROTA SUBSP. SATIVUS SEED9M6AAX381UIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
AVOCADO OIL6VNO72PFC1IACT
POPULUS TREMULOIDES BARK5543O0CEIDIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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
2aa00163-fe53-0568-e063-6394a90aebdad6464989-b334-4fea-8f2c-81f9ffdbe53c2025-01-01WarningsExact identifier
spl set id: d6464989-b334-4fea-8f2c-81f9ffdbe53c

Reported adverse events (FAERS/openFDA)#

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