ABSOLUTE FINISH FOUNDATION SPF15- octinoxate and titanium dioxide 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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Absolute Finish Foundation SPF15

Drug Facts

Active Ingredients

Octinoxate 7.5%, Titanium Dioxide 2.0%

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

Cyclopentasiloxane, Tribehenin, Dimethicone Crosspolymer, Cyclohexasiloxane, Octyldodecyl Neopentanoate, Emu Oil, Dimethicone, Tocopheryl Acetate, Retinyl Palmitate, Ascorbic Acid, Salicylic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol, Mica, Titanium Dioxide, Iron Oxides.

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 - 15 mL Jar Carton

ERNO
LASZLO

NEW YORK

ABSOLUTE FINISH

FOUNDATION SPF 15

15mL e 0.5 fl.oz.

Principal Display Panel - 15 mL Jar Carton
ABSOLUTE FINISH FOUNDATION SPF15 
octinoxate and titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2900
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Emu Oil (UNII: 344821WD61)  
Dimethicone (UNII: 92RU3N3Y1O)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Salicylic Acid (UNII: O414PZ4LPZ)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Mica (UNII: V8A1AW0880)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57913-2900-9 1 in 1 CARTON
1 15 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(57913-2900) , LABEL(57913-2900) , PACK(57913-2900)

Revised: 4/2013
Document Id: a711fc5c-534b-400a-bc28-431b4bb59977
Set id: 70422e2f-072e-4a2a-9f8c-5d8e5a271924
Version: 1
Effective Time: 20130408
 
Erno Laszlo, Inc.