Label: PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43- sunscreen lotion
- NDC Code(s): 60232-0007-1
- Packager: Swiss-American CDMO, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 7, 2023
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- Official Label (Printer Friendly)
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Warnings
For external use only. Do not use on damaged or broken skin. Stope use and ask doctor if rash occurs. When using the product keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control immediately. Protect this product from excessive heat and direct sun.
- Uses
- Uses
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Directions
Apply liberally 15 minutes before exposure to the sun. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age, ask physician. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
- Active Ingredients
- Keep out of reach of children
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Other Ingredients
Water, Isopropyl Palmitate, Octyl Stearate, Ethylhexyl Isononanoate, Cylcopentasiloxane, Cetearyl Glucoside, Dimethicone, Glycerth-26, Sodium Hyaluronate, Panthenol, Allantoin, Tocopheryl Acetate, Ascorbyl Palmitate, Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylopropane Coconut Ether, Polyether-1, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylysilane
- Labeling
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INGREDIENTS AND APPEARANCE
PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43
sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 75 g in 1000 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 g in 1000 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 25 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERETH-26 (UNII: NNE56F2N14) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) OCTYL STEARATE (UNII: 772Y4UFC8B) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) HYALURONIC ACID (UNII: S270N0TRQY) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60232-0007-1 50 g in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/07/2010 Labeler - Swiss-American CDMO, LLC (080170933) Registrant - Swiss-American CDMO, LLC (080170933) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(60232-0007)
