Label: ELTAMD UV SHIELD SPF45- zinc oxide and octinoxate sunscreen lotion
- NDC Code(s): 72043-2282-0, 72043-2282-1, 72043-2282-3, 72043-2282-8
- Packager: CP Skin Health Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Warnings
- Active Ingredients
- Uses
- Uses
-
Directions
apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. reapply at lest 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
-
Inactive Ingredients
Purified Water, Isopropyl Palmitate, Octyl Stearate, Cetearyl Alcohol, Polysorbate 60, Oleth-3 Phosphate, Phenoxyethanol, Cetearyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Polyether-1, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane
- KEEP OUT OF REACH OF CHILDREN
- Labeling
-
INGREDIENTS AND APPEARANCE
ELTAMD UV SHIELD SPF45
zinc oxide and octinoxate sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72043-2282 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 WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) OCTYL STEARATE (UNII: 772Y4UFC8B) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 60 (UNII: CAL22UVI4M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 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:72043-2282-3 85 g in 1 TUBE; Type 0: Not a Combination Product 01/10/2018 2 NDC:72043-2282-8 198 g in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2018 07/07/2022 3 NDC:72043-2282-1 50 g in 1 TUBE; Type 0: Not a Combination Product 04/20/2022 4 NDC:72043-2282-0 10.5 g in 1 TUBE; Type 0: Not a Combination Product 04/20/2022 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(72043-2282)
