Label: ALOE UP KIDS BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene, octinoxate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0301-4 - 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 May 4, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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 (Green Tea) 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
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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. Keep away from face to avoid breathing it.
Stop 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.
- Purpose
- Uses
- Active Ingredients
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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 valvue of 15 or higher and other sun protecion measures including:
- limit tim ein the sun, especially from 10am-2pm
- wear long sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other Information
- Questions or Comments?
- ALOE UP KIDS SPORT PERFORMANCE SUNSCREEN Broad spectrum SPF 50
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INGREDIENTS AND APPEARANCE
ALOE UP KIDS BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, avobenzone, homosalate, octocrylene, octinoxate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 49.7 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 99.4 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.82 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.7 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 59.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) SORBITOL (UNII: 506T60A25R) PROPANEDIOL (UNII: 5965N8W85T) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) COCOA BUTTER (UNII: 512OYT1CRR) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ALLANTOIN (UNII: 344S277G0Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) 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:58443-0301-4 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/03/2018 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0301) , manufacture(58443-0301) , label(58443-0301) , analysis(58443-0301)
