Label: MIAMI BEACH KIDS SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0256-4 - 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 January 17, 2020
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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 40 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 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
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Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Beta-Carotene, C12-15 Alkyl Benzoate, Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Prunus Armeniaca (Apricot) Kernel Oil, Pseudopterogorgia Elisabethae Plant Extract, Rosmarinus Officinalis (Rosemarry) Leaf Extract, Sodium Hydroxide, Solanum Lycopersicum (Tomato) Fruit/Leaf/Stem Extract, Sorbitan Oleate, Styrene/Acrylates Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Zea Mays (Corn) Oil
- Other information
- Miami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50
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INGREDIENTS AND APPEARANCE
MIAMI BEACH KIDS SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0256 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.76 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.6 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.28 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) CARBOMER 1342 (UNII: 809Y72KV36) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) SUNFLOWER OIL (UNII: 3W1JG795YI) CORN OIL (UNII: 8470G57WFM) .BETA.-CAROTENE (UNII: 01YAE03M7J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) APRICOT KERNEL OIL (UNII: 54JB35T06A) SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0) ROSEMARY (UNII: IJ67X351P9) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color white (White to Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0256-4 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/15/2017 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0256) , manufacture(58443-0256) , label(58443-0256) , analysis(58443-0256)
