Label: ABSOLUTE FINISH FOUNDATION SPF15- octinoxate and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 57913-2900-9 - Packager: Erno Laszlo, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 8, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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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
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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
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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
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Jar Carton
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INGREDIENTS AND APPEARANCE
ABSOLUTE FINISH FOUNDATION SPF15
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2900 Route of Administration TOPICAL 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)
