EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30- avobenzone, octinoxate, octisalate, oxybenzone lotion 
Extrashade a Sub of Versitile Group

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.

----------

EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30

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

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)

Drug Facts

Extra Shade 1

image description

Extra Shade 2

image description

EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42338-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42338-001-041 in 1 CARTON01/06/2012
1120 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 finalpart35201/06/2012
Labeler - Extrashade a Sub of Versitile Group (078350581)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture(42338-001)

Revised: 11/2018
Document Id: 7bd315bc-409f-54c2-e053-2991aa0a20b9
Set id: d197dfe3-c754-4a3d-9edd-335f3fce105c
Version: 3
Effective Time: 20181129
 
Extrashade a Sub of Versitile Group