Your browser does not support JavaScript! ABSOLUTE FINISH FOUNDATION SPF15 (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ERNO LASZLO, INC.]
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ABSOLUTE FINISH FOUNDATION SPF15 (octinoxate and titanium dioxide) lotion
[Erno Laszlo, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredients

Octinoxate 7.5%, Titanium Dioxide 2.0%

Purpose

Sunscreen

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. 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 40 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
    • children under 6 months: Ask a doctor

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

  • protect this product from excessive heat and direct sun

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57913-2900
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 mL
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 
Tribehenin 
Cyclomethicone 6 
Octyldodecyl Neopentanoate 
Emu Oil 
Dimethicone 
.Alpha.-Tocopherol Acetate 
Vitamin A Palmitate 
Ascorbic Acid 
Salicylic Acid 
Triethoxycaprylylsilane 
Phenoxyethanol 
Caprylyl Glycol 
Hexylene Glycol 
Mica 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2900-91 in 1 CARTON
115 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(57913-2900), LABEL(57913-2900), PACK(57913-2900)

Revised: 4/2013
 
Erno Laszlo, Inc.

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