EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30- avobenzone, octinoxate, octisalate, oxybenzone lotion

EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 by

Drug Labeling and Warnings

EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Extrashade a Sub of Versitile Group, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active ingredients                                Purpose
Avobenzone 3.0%
Octinoxate 7.5%Sunscreen      }        Sunscreen
Octisalate 5.0%
Oxybenzone 4.0%

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children

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

Directions

apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive ingredients

Water (Aqua), Glyceryl Stearate, Ethylhexyl Methoxycrylene, Glycerin, Jojoba Esters, Dimethicone, VP/Eicosene Copolymer, Cetearyl Alcohol, Cetyl Dimethicone, Potassium Cetyl Phosphate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Tocopheryl Acetate, Tertrahexyldecyl Ascorbate, Sodium Hyaluronate, Hydroxyethylcellulose, Hexylene Glycol, Punica Granatum Quillaja (Pomegranate) Extract, Cocos Nucifera (Coconut) Extract, Hedychium Coronarium Root (White Ginger) Extract, Actinidia Chinensis (Kiwi Fruit) Extract, Hibiscus Rosa Sinensis Extract, Passion Flora Incarnata (Passion Flower) Extract, Plantago Major Leaf (Plantain) Extract, Saponaria Bark (Soap Bark) Extract

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-637-5724

Purpose

Sunscreen

Description

EXTRASHADE SUN  PROTECTION FOR RICH COMPLEXIONS BROAD SPECTRUM SPF 30

PRINCIPAL DISPLAY PANEL

EXTRASHADE SUN PROTECTION FOR RICH COMPLEXIONS  BROAD SPECTRUM SPF 30  DAILY DEFENSE HYDRATING SUNSCREEN LOTION  WATER RESISTANT (80 MINUTES) PABA FREE  FRAGRANCE FREE OIL FREE DYE FREE  FACE AND BODY  PROTECTION FOR ACTIVE LIFESTYLE  4.0 Fl Oz (120ml)

PRINCIPAL DISPLAY PANEL

Drug Facts

Extra Shade 1

Extra Shade 2

INGREDIENTS AND APPEARANCE

EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42338-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COCONUT (UNII: 3RT3536DHY)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
KIWI FRUIT (UNII: 71ES77LGJC)
HIBISCUS ROSA-SINENSIS FLOWERING TOP (UNII: X9SED65819)
PASSIFLORA EDULIS FLOWER (UNII: SY49TH8VUA)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42338-001-04	1 in 1 CARTON	01/06/2012
1		120 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 not final	part352	01/06/2012

Labeler - Extrashade a Sub of Versitile Group (078350581)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(42338-001)