HARRYS DAILY FACIAL SPF BROAD SPECTRUM- zinc oxide lotion

Harrys Daily Facial SPF Broad Spectrum by

Drug Labeling and Warnings

Harrys Daily Facial SPF Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Harry's, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 6.6%

Purpose

Sunscreen

Use

Helps 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 develops and lasts

KEEP OUT OF REACH OF CHILDREN

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

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure and as needed

re-apply at least every two hours

use a water-resistant sunscreen if swimming or sweating

children under 6 months: 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, 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.

wear long-sleeve shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butylene Glycol, Dimethicone,Shea Butter Ethyl Esters, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, Salix Alba (Willow) Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopheryl Acetate, Caffeine, Polyacrylamide, Steareth-100, C13-14 Isoparaffin, Xanthan Gum, Caprylyl Glycol, Polysorbate 20, Citric Acid, Potassium Sorbate, Laureth-7, Sodium Polyacrylate, Hexylene Glycol,

Phenoxyethanol, Chlorphenesin, Limonene.

New Carton and Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARRYS DAILY FACIAL SPF BROAD SPECTRUM 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70533-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	66 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAFFEINE (UNII: 3G6A5W338E)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
CHLORPHENESIN (UNII: I670DAL4SZ)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERIN (UNII: PDC6A3C0OX)
SALIX ALBA BARK (UNII: 205MXS71H7)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
XANTHAN GUM (UNII: TTV12P4NEE)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
STEARETH-100 (UNII: 4OH5W9UM87)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70533-016-50	1 in 1 CARTON	04/01/2016
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2016

Labeler - Harry's, Inc. (079239206)