Label: R.E.M. DAY SPF 30- avobenzone, octinoxate and octisalate lotion
- NDC Code(s): 57913-2834-9
- 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
Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%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
Water, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Beeswax, Bisabolol, Ethylhexylglycerin, Hydroxyethylcellulose, Lecithin, Micrococcus Lysate, Retinyl Palmitate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Corylus Avellana (Hazel) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame) Seed Oil, Taraktogenos Kurzii Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Panax Ginseng Root Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Algae Extract, Plankton Extract, Sodium Hyaluronate, Sodium PCA, Steareth –20, Disodium EDTA, Phenoxyethanol, O-Cymen-5-Ol, Fragrance.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. BYClose
ERNO LASZLO NEW YORK, NY 10001
- PRINCIPAL DISPLAY PANEL - 90 mL Bottle Carton
DAY LOTION SPF 30
90mL e 3.0 fl.oz.
- INGREDIENTS AND APPEARANCE
R.E.M. DAY SPF 30
avobenzone, octinoxate, and octisalate lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2834 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (Avobenzone) Avobenzone 30 mg in 1 mL Octinoxate (Octinoxate) Octinoxate 75 mg in 1 mL Octisalate (Octisalate) Octisalate 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water Alkyl (C12-15) Benzoate Octyldodecyl Neopentanoate Butylene Glycol Glycerin Glyceryl Monostearate PEG-100 Stearate Yellow Wax Levomenol Ethylhexylglycerin Vitamin A Palmitate .Alpha.-Tocopherol Acetate Tetrahexyldecyl Ascorbate European Hazelnut Oil Sunflower Oil Avocado Oil Sesame Oil Hydnocarpus Kurzii Seed Oil Jojoba Oil Ginkgo Aloe Vera Leaf Asian Ginseng Centella Asiatica Echinacea Purpurea Hyaluronate Sodium Sodium Pyrrolidone Carboxylate Steareth-20 Edetate Disodium Phenoxyethanol O-Cymen-5-Ol Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57913-2834-9 1 in 1 CARTON 1 90 mL in 1 BOTTLE 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(57913-2834), LABEL(57913-2834), PACK(57913-2834)