Dynamic Broad Spectrum (Octinoxate And Zinc Oxide) Lotion [Prescriber's Choice Inc.] -

DYNAMIC BROAD SPECTRUM (OCTINOXATE AND ZINC OXIDE) LOTION [PRESCRIBER'S CHOICE INC.]
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NDC	71876-002-50
Set ID	01152a2b-a34c-4bc0-a53a-d0b565608a45
Category	HUMAN OTC DRUG LABEL
Packager	Prescriber's Choice Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

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.
SPL UNCLASSIFIED SECTION

Distributed By:
Ramsammy Medical
53 West Merrick Road
Freeport NY 11520
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

RAMSAMMY MEDICAL
R

Dynamic
Broad Spectrum

Sunscreen SPF55
Sun Protection

1.75 fl oz (50ml)

INGREDIENTS AND APPEARANCE

DYNAMIC BROAD SPECTRUM
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71876-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	48 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71876-002-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2017

Labeler - Prescriber's Choice Inc. (079728992)

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