Label: APOSTROPHE SCREEN SPF43- sunscreen lotion
- NDC Code(s): 81780-007-02, 81780-007-03
- Packager: Yoderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 7, 2023
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- Official Label (Printer Friendly)
- Warnings
- Active Ingredients
- Uses
- Uses
- KEEP OUT OF REACH OF CHILDREN
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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 and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
- Other Information
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Inactive Ingredients
purified water, isopropyl palmitate, ethylhexyl stearate, ethylhexyl isononanoate, cyclopentasiloxane, dimethicone, cetearyl glucoside, glycereth-26, phenoxyethanol, oleth-3 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, allantoin, polyisobutene, polyether-1, panthenol, butylene glycol, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, iodopropynyl butylcarbamate, ascorbyl palmitate, triethoxycaprylylsilane
- Labeling
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INGREDIENTS AND APPEARANCE
APOSTROPHE SCREEN SPF43
sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81780-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 25 g in 1000 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 g in 1000 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 75 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) GLYCERETH-26 (UNII: NNE56F2N14) PHENOXYETHANOL (UNII: HIE492ZZ3T) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) ALLANTOIN (UNII: 344S277G0Z) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) PANTHENOL (UNII: WV9CM0O67Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONIC ACID (UNII: S270N0TRQY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ASCORBYL PALMITATE (UNII: QN83US2B0N) 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:81780-007-03 1 in 1 CARTON 04/09/2021 1 87 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:81780-007-02 2 g in 1 PACKET; Type 0: Not a Combination Product 04/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/09/2021 Labeler - Yoderm, Inc. (079220017) Registrant - Swiss-American CDMO, LLC (080170933) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(81780-007)
