Label: ELTAMD UV CLEAR SPF46- zinc oxide and octinoxate sunscreen lotion
- NDC Code(s): 72043-2500-1, 72043-2500-2, 72043-2500-5
- Packager: CP Skin Health Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
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- Warnings
- Active Ingredients
- Uses
- Uses
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Directions
apply liberally to face and neck 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply 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 physician
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Inactive Ingredients
Purified water, Cyclopentasiloxane, Niacinamide, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Lactic Acid, Oleth-3 Phosphate, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane
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- Labeling
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INGREDIENTS AND APPEARANCE
ELTAMD UV CLEAR SPF46
zinc oxide and octinoxate sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72043-2500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 90 g in 1000 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 g in 1000 g Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) LACTIC ACID (UNII: 33X04XA5AT) HYALURONATE SODIUM (UNII: YSE9PPT4TH) NIACINAMIDE (UNII: 25X51I8RD4) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) OCTYLDODECYL BENZOATE (UNII: R04N7AS5EA) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72043-2500-1 48 g in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2018 2 NDC:72043-2500-5 14 g in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2020 3 NDC:72043-2500-2 2 g in 1 PACKET; Type 0: Not a Combination Product 07/06/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/10/2018 Labeler - CP Skin Health Group, Inc. (611921669) Registrant - Swiss-American CDMO, LLC (080170933) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(72043-2500)
