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 Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2832
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Shea Butter (UNII: K49155WL9Y)  
Emu Oil (UNII: 344821WD61)  
Glycerin (UNII: PDC6A3C0OX)  
PEG-100 Stearate (UNII: YD01N1999R)  
Myristyl Alcohol (UNII: V42034O9PU)  
Coco Glucoside (UNII: ICS790225B)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Dimethicone (UNII: 92RU3N3Y1O)  
Hydnocarpus Kurzii Seed Oil (UNII: N757YEZ18Q)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Asian Ginseng (UNII: CUQ3A77YXI)  
Allantoin (UNII: 344S277G0Z)  
Ceteth-20 (UNII: I835H2IHHX)  
Edetate Disodium (UNII: 7FLD91C86K)  
O-Cymen-5-Ol (UNII: H41B6Q1I9L)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Steareth-2 (UNII: V56DFE46J5)  
Steareth-20 (UNII: L0Q8IK9E08)  
Trolamine (UNII: 9O3K93S3TK)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57913-2832-9 1 in 1 CARTON
1 90 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/10/2013
Labeler - Erno Laszlo, Inc. (098821031)
Establishment
Name Address ID/FEI Business Operations
Mana Products 078870292 MANUFACTURE(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.