FDA.reportPublic FDA data

Bellame

Manufacturer
Prime Matter Labs West | Prime Enterprises
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:48

Label at a glance#

ProductBellame Broad Spectrum SPF 50
Active ingredientZINC OXIDE, OCTOCRYLENE, HOMOSALATE, OCTISALATE
Label structure9 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 children under 6 months: ask a doctor 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 of 15 or higher and other sun protection measu...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Zinc Oxide 5%

Octocrylene 5%

Octisalate 5%

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.

Stp use and ask a doctor

OTC - STOP USE SECTION

if rash 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
  • children under 6 months: ask a doctor
  • 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 of 15 or higher and other sun protection measures including
  • limit time in the sun, especially from 10 am - 2pm
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylic acid/vp crosspolymer, adansonia digitata seed oil, aloe barbadensis leaf juice, butyloctyl salicylate, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, disodium edta, ethyl ferulate, ethylhexylglycerin, glycerin, helianthus annuus (sunflower) seed oil, olea europaea (olive) fruit oil, phenoxyethanol, pongamia pinnata seed extract, rubus idaeus (raspberry) seed oil, simmondsia chinensis (jojoba) seed oil, sodium hydroxide, tocopheryl acetate, triethoxycaprylylsilane, vp/acrylates/lauryl methacrylate copolymer, water

Other Information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-833-235-5263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82956-000382956-0003-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ETHYL FERULATE5B8915UELWIACT
ZINC OXIDESOI2LOH54ZACTIB
SHEA BUTTERK49155WL9YIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
JOJOBA OIL724GKU717MIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SUNFLOWER OIL3W1JG795YIIACT
OLIVE OIL6UYK2W1W1EIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
LAURYL METHACRYLATEB6L83074BZIACT
RASPBERRY SEED OIL9S8867952AIACT
N-VINYLPYRROLIDINONE76H9G81541IACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ACRYLIC ACIDJ94PBK7X8SIACT
GLYCERINPDC6A3C0OXIACT

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
1790046f-0733-6094-e063-6294a90a73291790046f-0732-6094-e063-6294a90a73292024-05-03WarningsExact identifier
spl id: 1790046f-0733-6094-e063-6294a90a7329
spl set id: 1790046f-0732-6094-e063-6294a90a7329

Reported adverse events (FAERS/openFDA)#

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