PRIVATE LABEL SUNSCREEN SPF35 40MIN WR RE126-202- homosalate, zinc oxide sunscreen lotion 
Swiss-American CDMO, LLC

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Private Label Sunscreen SPF35 40min WR RE126-202

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

Homosalate 9.0% Sunscreen
Zinc Oxide 10.0% Sunscreen
Octisalate 5.0% 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.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 40 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Keep out of reach of children

Keep out of reach of children

Other information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, dimethicone, PEG-10 dimethicone, euphorbia cerifera (Candelilla) Wax, Caprylic/Capric Trigylceride, sodium chloride, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, saccharide isomerate, ethylhexylglycerin, dl-alpha tocopheryl acetate, glycerin, disodium EDTA, xanthan gum, Gossypium herbaceum (Cotton) extract, citric acid, sodium citrate, benzyl alcohol, gluconolactone, sodium benzoate, calcium gluconate

Questions?

Call toll free 1-866-416-2366

Labeling

PL036 Drug Facts

PRIVATE LABEL SUNSCREEN SPF35 40MIN WR RE126-202 
homosalate, zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CANDELILLA WAX (UNII: WL0328HX19)  
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
GLYCERIN (UNII: PDC6A3C0OX)  
GOSSYPIUM HIRSUTUM WHOLE (UNII: 0Z88765ZGC)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0036-130 g in 1 PACKAGE; Type 0: Not a Combination Product11/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/09/2023
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0036)

Revised: 11/2023
Document Id: fe000ceb-250f-465c-81cf-ed3d78f0e7f4
Set id: 254fa69f-2413-47e8-bc9b-5b7b0b59a5c8
Version: 1
Effective Time: 20231109
 
Swiss-American CDMO, LLC