PRESCRIBERS CHOICE DYNAMIC BROAD SPECTRUM- octinoxate and zinc oxide lotion 
Prescriber's Choice 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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Prescriber's Choice Dynamic Broad Spectrum

DRUG FACTS:

ACTIVE INGREDIENTS

Octinoxate 7.5, Zinc Oxide 4.8%

Purpose

Sunscreen

USES

Help prevent sunburn.

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 or irritation 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 and evenly 15 minutes before sun exposure. *Reapply: At least 80 minutes after 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am – 2 pm wear long-sleeve shirts, pants, hats, and sunglasses. *For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

Distributed By:
Prescriber's Choice
Pompano Beach, FL 33069

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

PRESCRIBER'S
CHOICE

Dynamic
Broad Spectrum

Sunscreen SPF55
Sun Protection

4 fl oz (120ml)

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label
PRESCRIBERS CHOICE DYNAMIC BROAD SPECTRUM 
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71876-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE48 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71876-003-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2017
Labeler - Prescriber's Choice Inc. (079728992)

Revised: 9/2018
Document Id: 7d162bbc-5617-4560-8e7f-c5480868db62
Set id: 3e3f9c88-3ae4-4e11-b7e4-ec1c1a9dcb74
Version: 1
Effective Time: 20180921
 
Prescriber's Choice Inc.