BELLAME BROAD SPECTRUM SPF 50- homosalate, zinc oxide, octocrylene, octisalate lotion

Bellame by

Drug Labeling and Warnings

Bellame by is a Otc medication manufactured, distributed, or labeled by Prime Matter Labs West, Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 10%

Zinc Oxide 5%

Octocrylene 5%

Octisalate 5%

Purpose

Sunscreen

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

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.

Stp use and ask a doctor

if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control center right away

Directions

• 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

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

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-833-235-5263

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BELLAME  BROAD SPECTRUM SPF 50
homosalate, zinc oxide, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82956-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50.25 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYL FERULATE (UNII: 5B8915UELW)
SHEA BUTTER (UNII: K49155WL9Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
JOJOBA OIL (UNII: 724GKU717M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
LAURYL METHACRYLATE (UNII: B6L83074BZ)
RASPBERRY SEED OIL (UNII: 9S8867952A)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLIC ACID (UNII: J94PBK7X8S)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82956-0003-3	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/03/2024

Labeler - Prime Matter Labs West (118568102)

Registrant - Prime Matter Labs West (118568102)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Matter Labs West		118568102	label(82956-0003) , manufacture(82956-0003) , pack(82956-0003)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(82956-0003)