MIAMI BEACH KIDS SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises Inc.

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.

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Miami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Purpose

Sunscreen

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

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.

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

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

• protect this product from excessive heat and direct sun. • may stain fabrics.

Miami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50

Principal Display Label

MIAMI BEACH  KIDS SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0256
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.76 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.6 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.28 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White to Off White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0256-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/15/2017
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0256) , manufacture(58443-0256) , label(58443-0256) , analysis(58443-0256)

Revised: 1/2020
Document Id: 9c59ea17-cd7e-7ccb-e053-2995a90ada4c
Set id: 678b9575-3271-9c42-e053-2a91aa0a5c91
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.