KERAS DAY SHIELD BROAD SPECTRUM SPF 25- octinoxate, avobenzone, and octocrylene lotion 
RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25- octinoxate, avobenzone, and octocrylene lotion 
Keraplast Technologies LLC

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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Day Shield Broad Spectrum SPF 25

Drug Facts

Active Ingredients

Octinoxate 5%

Avobenzone 3%

Octocrylene 8%

Purpose

Sunscreen

Uses

Warnings

For External use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

Inactive ingredients

Water, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Keratin, Hydrolyzed keratin, Glycerin, Sucrose Polybehenate, Gluconolactone, Sodium benzoate, Potassium sorbate, fragrance

Other information

Protect this product from excessive heat and direct sun

Manufactured in
New Zealand
for
Keraplast Technologies, LLC.
San Antonio, TX 78258

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

K
KERAS

DAY SHIELD
BROAD SPECTRUM
SPF 25

For All Skin Types

Net Contents
1.7 Fl.Oz./50 ml

Principal Display Panel - 50 ml Bottle Carton

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

RETROSPECT

DAY SHIELD
BROAD
SPECTRUM
SPF 25

For All Skin Types

Net Contents
1.7 Fl.Oz./50 ml

Principal Display Panel - 50 ml Bottle Carton
KERAS DAY SHIELD BROAD SPECTRUM SPF 25 
octinoxate, avobenzone, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24854-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate0.25 g  in 50 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone0.15 g  in 50 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene0.4 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
glycerin (UNII: PDC6A3C0OX)  
gluconolactone (UNII: WQ29KQ9POT)  
sodium benzoate (UNII: OJ245FE5EU)  
potassium sorbate (UNII: 1VPU26JZZ4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24854-400-501 in 1 CARTON
150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/30/2011
RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 
octinoxate, avobenzone, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24854-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate0.25 g  in 50 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone0.15 g  in 50 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene0.4 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
glycerin (UNII: PDC6A3C0OX)  
gluconolactone (UNII: WQ29KQ9POT)  
sodium benzoate (UNII: OJ245FE5EU)  
potassium sorbate (UNII: 1VPU26JZZ4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24854-300-501 in 1 CARTON
150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/30/2011
Labeler - Keraplast Technologies LLC (009952821)
Establishment
NameAddressID/FEIBusiness Operations
The Cosmetic Company590563383LABEL, MANUFACTURE, PACK

Revised: 11/2011
Document Id: 54e717a9-f442-48a5-8aac-eee89f00746d
Set id: 1a784b0e-a517-4510-a547-1334febfc0aa
Version: 1
Effective Time: 20111130
 
Keraplast Technologies LLC