DAILY FACE BROAD SPECTRUM- zinc oxide lotion 
Harry's, 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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Daily Face Lotion - Broad Spectrum SPF 15

Drug Facts

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.

If this product is swallowed, get medical help or contact a Poison Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure

• 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.

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, Streareth-100, C13-14 Isoparaffin, Xanthan Gum, Caprylyl Glycol, Polysorbate 20, Citric Acid, Potassium Sorbate, Laureth-7, Sodium Polyacrylate, Hexylene Glycol, Phenoxyethanol, Chlorphenesin

Other information

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

Questions or comments?

Call 1-888-212-6855

Package Labeling:

Outer LabelInner Label

DAILY FACE BROAD SPECTRUM 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70533-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION66 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAFFEINE (UNII: 3G6A5W338E)  
STEARETH-100 (UNII: 4OH5W9UM87)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LAURETH-7 (UNII: Z95S6G8201)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70533-001-501 in 1 CARTON04/03/2016
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2016
Labeler - Harry's, Inc. (079239206)

Revised: 4/2016
Document Id: 2fab0ad2-7453-53fc-e054-00144ff8d46c
Set id: b05b40a9-f02e-43a3-9546-81e14df86972
Version: 2
Effective Time: 20160404
 
Harry's, Inc.