Label: ABSOLUTE FINISH FOUNDATION SPF15- octinoxate and titanium dioxide lotion
- NDC Code(s): 57913-2900-9
- Packager: Erno Laszlo, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active Ingredients
Octinoxate 7.5%, Titanium Dioxide 2.0%Close
For external use only.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.
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.Close
- Other information
- protect this product from excessive heat and direct sun
- Questions or comments?
Call toll free at 866-452-7956.Close
- SPL UNCLASSIFIED SECTION
DISTRIBUTED IN U.S.A.Close
BY ERNO LASZLO NEW YORK, NY 10001
- PRINCIPAL DISPLAY PANEL - 15 mL Jar Carton
FOUNDATION SPF 15
15mL e 0.5 fl.oz.
- INGREDIENTS AND APPEARANCE
ABSOLUTE FINISH FOUNDATION SPF15
octinoxate and titanium dioxide lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2900 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 75 mg in 1 mL Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 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)