Label: ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene lotion
- NDC Code(s): 58443-0559-3
- 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 August 19, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 ine 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 value of 15 or higher and other sun protecion measures including:
- limit time in the sun, especially from 10am-2pm
- wear long sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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INACTIVE INGREDIENTS
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?
- Aloe Up Sport SPF 50 Broad Spectrum Performance Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, avobenzone, homosalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0559 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 148.95 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 99.4 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.79 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.65 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) COCOA BUTTER (UNII: 512OYT1CRR) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITOL (UNII: 506T60A25R) ALLANTOIN (UNII: 344S277G0Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) SODIUM HYDROXIDE (UNII: 55X04QC32I) 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:58443-0559-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 11/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 11/03/2020 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0559) , manufacture(58443-0559) , label(58443-0559) , analysis(58443-0559)
