Label: BELLAME BROAD SPECTRUM SPF 50- homosalate, zinc oxide, octocrylene, octisalate lotion
- NDC Code(s): 82956-0003-3
- Packager: Prime Matter Labs West
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BELLAME BROAD SPECTRUM SPF 50
homosalate, zinc oxide, octocrylene, octisalate lotionProduct 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)
