PHELITYL DAY SPF 15- avobenzone and octinoxate lotion 
Erno Laszlo, Inc.

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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Phelityl Day SPF 15

Drug Facts

Active Ingredients

Avobenzone 2%, Octinoxate 5%

Purpose

Sunscreen

Uses

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. If product is swallowed, get medical help or contact a Poison Control center right away.

Directions

Apply liberally 15 minutes before sun exposure

Inactive Ingredients

Water, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.

Other information

Questions or comments?

Call toll free at 866-452-7956.

DISTRIBUTED IN U.S.A. BY
ERNO LASZLO NEW YORK, NY 10001

PRINCIPAL DISPLAY PANEL - 90mL Jar Carton

ERNO
LASZLO

NEW YORK

PHELITYL

DAY LOTION SPF 15

90mL e 3.0 fl.oz.

PRINCIPAL DISPLAY PANEL - 90mL Jar Carton
PHELITYL DAY SPF 15 
avobenzone and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57913-2832
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone20 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glyceryl Monostearate 
Butylene Glycol 
Cetyl Alcohol 
Cyclomethicone 5 
Alkyl (C12-15) Benzoate 
Octyldodecyl Neopentanoate 
Silicon Dioxide 
Shea Butter 
Emu Oil 
Glycerin 
PEG-100 Stearate 
Myristyl Alcohol 
Coco Glucoside 
Ethylhexylglycerin 
Dimethicone 
Hydnocarpus Kurzii Seed Oil 
Aloe Vera Leaf 
Chamaemelum Nobile Flower 
Green Tea Leaf 
Asian Ginseng 
Allantoin 
Ceteth-20 
Edetate Disodium 
O-Cymen-5-Ol 
Tetrahexyldecyl Ascorbate 
.Alpha.-Tocopherol Acetate 
Steareth-2 
Steareth-20 
Trolamine 
Phenoxyethanol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2832-91 in 1 CARTON
190 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/10/2013
Labeler - Erno Laszlo, Inc. (098821031)
Establishment
NameAddressID/FEIBusiness Operations
Mana Products078870292MANUFACTURE(57913-2832), LABEL(57913-2832), PACK(57913-2832)

Revised: 4/2013
Document Id: 2e3ca0d0-6d4b-48f1-8bf6-fb492a49a84a
Set id: 5e2347cb-4139-4bd8-af80-9f0a9aa0f12b
Version: 1
Effective Time: 20130408
 
Erno Laszlo, Inc.