Dr. Evans Oil-Free DEFENSE DAY TINTED MOISTURIZER SPF 55 by Guthy-Renker, LLC. / AMCOL Health & Beauty Solutions, Incorporated / Thibiant, International, Inc.

Dr. Evans Oil-Free DEFENSE DAY TINTED MOISTURIZER SPF 55 by

Drug Labeling and Warnings

Dr. Evans Oil-Free DEFENSE DAY TINTED MOISTURIZER SPF 55 by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker, LLC., AMCOL Health & Beauty Solutions, Incorporated, Thibiant, International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. EVANS OIL-FREE DEFENSE DAY TINTED MOISTURIZER SPF 55- homosalate, octisalate, oxybenzone, avobenzone, octocrylene liquid 
THE PROACTIV COMPANY 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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SPL UNCLASSIFIED SECTION

Oil-Free

DEFENSE DAY TINTED

MOISTUIZER SPF 55

Purpose:

Sunscreen

Use:

Helps prevent sunburn, higher SPF gives more sunburn protection

Directions:

Apply to face every morning after cleansing.

Active Ingredients:

Oxybenzone 6.0%, Octocrylene 2.0%, Octisalate 5.0%, Avobenzone 3.0%, Homosalate 10.0%

Inactive Ingredients:

Water, Butylene Glycol, PEG-8, Polyethylene, Silica, Dimethicone, Picea Albies Wood Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopheryl, Methyl Glucose Sesquistearate, Glycerin, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Bentonite, Sodium Hydroxide, Sodium Polyacrylate, Disodium EDTA, Xanthan Gum, Ammonium Polyacrylate, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin, Alumina, Iron Oxides (C.I. 77492), Titanium Dioxide, Iron Oxides (C.I. 77491, Iron Oxides (C.I. 77499).

WARNINGS:

For external use only. Keep out of reach of children. Avoid eye area, if eye contact occurs, flush gently and thoroughly with water. Discontinue use if rash or irritation occurs. If irritation persists, consult your health care practitioner.

Within the USA Call 888-215-3891
DrEvans.com
Guthy-Renker®, LLC
P.O. Box 14383,
Palm Desert, CA 92555-4383,
London UK SW1Y 4HH,
Sydney, Australia 2138,
Auckland, New Zealand,
Toronto, Ontario M1X 1E7
Dr. Evans is a registered trademark of
TEC Production Corporation
Evans/Syal
DR. E tm

Principal Display Panel – 30 mL Tube

DR. Evans tm

Cosmeceuticals

BEVERLY HILLS

Oil-Free

DEFENSE DAY

TINTED

MOISTURIZER

SPF 55

30 ml E 1 fl oz

Principal Display Panel – 30 mL Tube
DR. EVANS OIL-FREE DEFENSE DAY TINTED MOISTURIZER SPF 55 
homosalate, octisalate, oxybenzone, avobenzone, octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERIN (UNII: PDC6A3C0OX)  
Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENTONITE (UNII: A3N5ZCN45C)  
PICEA ABIES WOOD (UNII: 72GZ8K8996)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-411-011 in 1 CARTON02/04/201101/01/2019
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/04/201101/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)
Establishment
NameAddressID/FEIBusiness Operations
AMCOL Health & Beauty Solutions, Incorporated872684803manufacture(11410-411)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant, International, Inc.083913913manufacture(11410-411)

Revised: 1/2020
 
THE PROACTIV COMPANY LLC