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

retrospect day shield broad spectrum SPF 25 by

Drug Labeling and Warnings

retrospect day shield broad spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by Keraplast Technologies LLC, The Cosmetic Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 5%

Avobenzone 3%

Octocrylene 8%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin aging caused by the sun

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

• Apply in the morning over intensive serum as a moisturizing sunscreen. Smooth over face and neck, massaging in upward, outward, circular motions.
• Apply at least 15 minutes before sun exposure.
• Reapply every 2 hours if skin is being exposed to the sun.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early signs of 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 to 2 pm
  • Wear long sleeved shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

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

SPL UNCLASSIFIED SECTION

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

RETROSPECT

DAY SHIELD
BROAD
SPECTRUM
SPF 25

For All Skin Types

Net Contents
1.7 Fl.Oz./50 ml

INGREDIENTS AND APPEARANCE

KERAS DAY SHIELD BROAD SPECTRUM SPF 25 
octinoxate, avobenzone, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24854-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	0.25 g  in 50 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	0.15 g  in 50 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	0.4 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24854-400-50	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/30/2011

RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 
octinoxate, avobenzone, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24854-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	0.25 g  in 50 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	0.15 g  in 50 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	0.4 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24854-300-50	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/30/2011

Labeler - Keraplast Technologies LLC (009952821)

Establishment
Name	Address	ID/FEI	Business Operations
The Cosmetic Company		590563383	LABEL, MANUFACTURE, PACK