Label: PHELITYL DAY SPF 15- avobenzone and octinoxate lotion
- NDC Code(s): 57913-2832-9
- Packager: Erno Laszlo, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 7, 2023
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- 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
Water, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Product label
-
INGREDIENTS AND APPEARANCE
PHELITYL DAY SPF 15
avobenzone and octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2832 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETYL ALCOHOL (UNII: 936JST6JCN) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SHEA BUTTER (UNII: K49155WL9Y) EMU OIL (UNII: 344821WD61) GLYCERIN (UNII: PDC6A3C0OX) PEG-100 STEARATE (UNII: YD01N1999R) MYRISTYL ALCOHOL (UNII: V42034O9PU) COCO GLUCOSIDE (UNII: ICS790225B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE (UNII: 92RU3N3Y1O) HYDNOCARPUS KURZII SEED OIL (UNII: N757YEZ18Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ASIAN GINSENG (UNII: CUQ3A77YXI) ALLANTOIN (UNII: 344S277G0Z) CETETH-20 (UNII: I835H2IHHX) EDETATE DISODIUM (UNII: 7FLD91C86K) O-CYMEN-5-OL (UNII: H41B6Q1I9L) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) TROLAMINE (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57913-2832-9 1 in 1 CARTON 04/10/2013 1 90 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/10/2013 Labeler - Erno Laszlo, Inc. (098821031) Establishment Name Address ID/FEI Business Operations Mana Products 078870292 manufacture(57913-2832)
