SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20- zinc oxide, octinoxate lotion

Sunscreen with UV pearls Broad Spectrm SPF 20 by

Drug Labeling and Warnings

Sunscreen with UV pearls Broad Spectrm SPF 20 by is a Otc medication manufactured, distributed, or labeled by Isomers Laboratories Inc, Isomers laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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Active Ingredients:

Zinc Oxide                           8.0%

Octyl Methoxycinnamate      7.5%

PURPOSE

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Purpose

Sunscreen

INDICATIONS & USAGE

• helps prevent sunburn
• if used as directed with other sun protection measures (See Direction ),decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

• For external use only
• When using this product, keep out of eyes.Rinse with watewr to remove.

Do Not Use on damaged or broken skin

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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• Keep out of reach of children
• If product is swallowed get medical help or contact the Poison Control Center right away.

INACTIVE INGREDIENT

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Inactive Ingredients:

Purified Water, Cetearyl Alcohol, Phenyl Trimethicone, Caprylic/Capric Triglyceride, Propylen Glycol, Ceteareth-20, Polyhydroxystearic Acid, Mineral Oil, Panthenol, Silica, PVP, Chlorphenesin, Tocopheryl Acetate, Aloe Barbadensis Leaf extract, Polysorbate 60, BHT, Phenoxyethanol, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben.

DOSAGE & ADMINISTRATION

• Apply Liberally 15 minutes before sun exposure.
• reapply at least every two hours
• use a water -resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor.
• Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures.
• Limit time in the sun especially from 10 a.m. to 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses.

PRINCIPAL DISPLAY PANEL

MM10

INGREDIENTS AND APPEARANCE

SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20 
zinc oxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64990-885
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	Zinc Oxide	80 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polysorbate 60 (UNII: CAL22UVI4M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Chlorphenesin (UNII: I670DAL4SZ)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Panthenol (UNII: WV9CM0O67Z)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64990-885-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/31/2003

Labeler - Isomers Laboratories Inc (253306799)

Registrant - Isomers Laboratories Inc (253306799)

Establishment
Name	Address	ID/FEI	Business Operations
Isomers laboratories Inc		253306799	manufacture(64990-885)