Label: ALOE UP SPORT SPF-15- avobenzone, homosalate, octisalate, octocrylene lotion
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- NDC Code(s): 61477-217-14
- Packager: Aloe Care International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 13, 2022
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- ACTIVE INGREDIENTS
- PURPOSE
- INDICATIONS
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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 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 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 of age: Ask a doctor - KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Carbomer, Iodopropynyl Butylcarbamate, Isodecyl Neopentanoate, Isopropylphthalimide, PEG-8, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sorbitol,
Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Trisodium Ethylenediamine Disuccinate, Water - OTHER INFORMATION
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INGREDIENTS AND APPEARANCE
ALOE UP SPORT SPF-15
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-217 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) 3-BUTYLPHTHALIDE (UNII: 822Q956KGM) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPANEDIOL (UNII: 5965N8W85T) SORBITOL (UNII: 506T60A25R) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61477-217-14 177 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/24/2014 Labeler - Aloe Care International, LLC (938242187) Registrant - Aloe Care International, LLC (938242187)
