APOSTROPHE SCREEN SPF43- sunscreen lotion 
Yoderm, Inc.

----------

Apostrophe Screen SPF43

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 7.5% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate  2.5% Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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

Protect this product from excessive heat and direct sun.

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

Apostrophe UC

APOSTROPHE SCREEN SPF43 
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81780-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE25 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION75 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81780-007-031 in 1 CARTON04/09/2021
187 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:81780-007-022 g in 1 PACKET; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/09/2021
Labeler - Yoderm, Inc. (079220017)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(81780-007)

Revised: 11/2023
Document Id: 50dea822-3b7c-4d26-bdf7-3f82d7413625
Set id: c8b5d993-57f4-4960-bdba-716bf5dadbb4
Version: 2
Effective Time: 20231107
 
Yoderm, Inc.