Label: PALM ISLAND BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene lotion
- NDC Code(s): 58443-0584-8
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 10, 2022
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- 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
- 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 broad spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
INACTIVE INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Ethylhexylglycerin, Isodecyl Neopentanoate, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sodium Hydroxide, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Water
- Other Information
- Questions or Comments?
- Palm Island Broad Spectrum SPF 50 Sunscreen Lotion
-
INGREDIENTS AND APPEARANCE
PALM ISLAND BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0584 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 152.53 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.85 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 101.7 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.51 g in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GREEN TEA LEAF (UNII: W2ZU1RY8B0) COCOA BUTTER (UNII: 512OYT1CRR) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALLANTOIN (UNII: 344S277G0Z) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) SORBITOL (UNII: 506T60A25R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) Product Characteristics Color white (off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0584-8 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/10/2022 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0584) , manufacture(58443-0584) , label(58443-0584) , analysis(58443-0584)
