PRIVATE LABEL SUPER LIGHT OIL-FREE SPF45- 2.75% octinsalate, 7.50% octinoxate, 8.00% zinc oxide sunscreen lotion 
Swiss-American CDMO, LLC

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Private Label Super Light Oil-Free SPF45

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

Use 

Helps prevent sunburn. 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.

Use

Helps prevent sunburn. 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 sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10a.m. to 2p.m. Wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

Keep out of reach of children

Keep out of reach of children

Active Ingredients

Octinoxate 7.50%

Octisalate 2.75%

Zinc Oxide 8.00%

Inactive Ingredients

Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acrylouldimethyl Taurate Copolymer, Idodopropynyl Butylcarbamate, Octyldodecyl neopentanoate, Oleth-3 Phosphate, PEG-7 Triethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Purified Water, Retinyl Palmitate, Triethocycaprylysilane

Labeling

PL008 Artwork

PRIVATE LABEL SUPER LIGHT OIL-FREE SPF45 
2.75% octinsalate, 7.50% octinoxate, 8.00% zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE27.5 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75.0 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80.0 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0008-260 g in 1 BOTTLE; Type 0: Not a Combination Product03/22/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/22/2011
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0008)

Revised: 11/2023
Document Id: c9d33e9b-77bd-4ca7-b228-f49318307a70
Set id: 6a08448a-46bc-4330-ae2d-f716bb4edfa7
Version: 3
Effective Time: 20231107
 
Swiss-American CDMO, LLC