PRIVATE LABEL SPF45 WATER RESISTANT PARABEN FREE SUNSCREEN- octinoxate, octisalate, zinc oxide sunscreen lotion 
Swiss-American CDMO, LLC

----------

Private Label SPF45 Water Resistant Paraben Free Sunscreen

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 physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 a.m. – 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Keep Out of Reach of Children

Keep Out of Reach of Children

Active Ingredients

Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Cylcopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isonnonanoate, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethyoxycaprylylsilane

Labeling

PL006 Artwork

PRIVATE LABEL SPF45 WATER RESISTANT PARABEN FREE SUNSCREEN 
octinoxate, octisalate, zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0006-150 g in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/2011
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0006)

Revised: 11/2023
Document Id: 21e18883-f579-425a-a460-1e601e1b30be
Set id: f997f4fc-7da5-433c-9a53-2030b489b4f6
Version: 3
Effective Time: 20231107
 
Swiss-American CDMO, LLC