Label: ELTAMD UV SPF 30 PLUS- zinc oxide and octinoxate sunscreen lotion
- NDC Code(s): 72043-2286-2, 72043-2286-8
- 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 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 another sun protection measures including: limit time in the sun, expecially from 10 am - 2 pm wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician
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Inactive Ingredients
purified water, petrolatum, isopropyl palmitate, octyl stearate, glyceryl stearate, cetearyl glucoside, dimethicone, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl tautrate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, ployether-1, citric acid, oleth-3 phosphate, phenoxyethanol, butylene glycol, iodopropynyl butylcarbamate, triethoxycaprylylsilane
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- Labeling
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INGREDIENTS AND APPEARANCE
ELTAMD UV SPF 30 PLUS
zinc oxide and octinoxate sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72043-2286 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 70 g in 1000 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) OCTYL STEARATE (UNII: 772Y4UFC8B) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72043-2286-8 198 g in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2018 2 NDC:72043-2286-2 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(72043-2286)
