PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43- sunscreen lotion 
Swiss-American CDMO, LLC

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Private Label Moisturizing Oil Free Paraben Free SPF43

Warnings

For external use only.  Do not use on damaged or broken skin.  Stope use and ask doctor if rash occurs. When using the product keep out of eyes; rinse with water to remove.  Keep out of reach of children.  If swallowed, get medical help or contact poison control immediately.  Protect this product from excessive heat and direct sun.

Uses

Helps prevent sunbrun an dphoto damage caused by UVA/UVB exposure.  If used as directed with other sun protection measures (see directions) , decreases the risk of skin cancer and early skin aging caused by the sun.

Uses

Helps prevent sunbrun an dphoto damage caused by UVA/UVB exposure.  If used as directed with other sun protection measures (see directions) , decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

Apply liberally 15 minutes before exposure to the sun. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age, ask physician. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Active Ingredients

Zinc Oxide   7.50%

Octinoxate   7.50%

Octisalate   2.50%

Keep out of reach of children

Keep out of reach of children.

Other Ingredients

Water, Isopropyl Palmitate, Octyl Stearate, Ethylhexyl Isononanoate, Cylcopentasiloxane, Cetearyl Glucoside, Dimethicone, Glycerth-26, Sodium Hyaluronate, Panthenol, Allantoin, Tocopheryl Acetate, Ascorbyl Palmitate, Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylopropane Coconut Ether, Polyether-1, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylysilane

Labeling

PL007 Artwork

PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43 
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION75 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE25 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERETH-26 (UNII: NNE56F2N14)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0007-150 g in 1 BOTTLE; Type 0: Not a Combination Product05/07/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/07/2010
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0007)

Revised: 11/2023
Document Id: 4e399a9d-b92c-4483-962a-4d65f8cddc30
Set id: 003e4221-f9d9-47c4-b10b-9876046b931a
Version: 2
Effective Time: 20231107
 
Swiss-American CDMO, LLC