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EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30

Dosage form: lotion
Ingredients: AVOBENZONE 3.0mL in 100mL, OCTINOXATE 7.5mL in 100mL, OCTISALATE 5.0mL in 100mL, OXYBENZONE 4.0mL in 100mL
Labeler: Extrashade a Sub of Versitile Group
NDC Code: 42338-001

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

Extra Shade 2

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
GLYCERIN 
DIMETHICONE 
CETOSTEARYL ALCOHOL 
POTASSIUM CETYL PHOSPHATE 
PEG-100 STEARATE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
ALPHA-TOCOPHEROL ACETATE 
HYALURONATE SODIUM 
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION) 
HEXYLENE GLYCOL 
COCONUT 
HEDYCHIUM CORONARIUM ROOT 
KIWI FRUIT 
HIBISCUS ROSA-SINENSIS FLOWERING TOP 
PASSIFLORA EDULIS FLOWER 
PLANTAGO MAJOR LEAF 
SAPONARIA OFFICINALIS ROOT 
Packaging
#Item CodePackage Description
1NDC:42338-001-041 BOTTLE (BOTTLE) in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/06/2012
Labeler - Extrashade a Sub of Versitile Group (078350581)
Establishment
NameAddressID/FEIOperations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture

Revised: 01/2012
 
Extrashade a Sub of Versitile Group

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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