PRIVATE LABEL SPF 50 80 MIN WATER RESISTANT- homosalate, octisalate, zinc oxide sunscreen cream 
Swiss-American CDMO, LLC

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Private Label SPF 50 80 min Water Resistant

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.

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   

Active Ingredients

Homosalate 10.0% Sunscreen
Octisalate 5.0%
Zinc Oxide 16.5% Sunscreen

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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other safety information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

C15-19 Alkane, Calcium gluconate, citric acid, dimethicone, disodium EDTA, disteardimonium hectorite, ethylhexylglycerin, gluconolactone, Gossypium hirsutum (cotton) extract, glycerin, glyceryl behenate, hydrogenated polyisobutene, lecithin, octyldodecyl neopentanoate, phenoxyethanol, polyglyercyl-2 isostearate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, polysilicone-11, pullulan, saccharide isomerate, sclerotium gum, silica, sodium benzoate, sodium chloride, sodium citrate, sodium hydroxide, sodium olivate, tocopherol, tocopheryl acetate, triethoxycaprylysilane, xanthan gum, water

Questions?

Call toll free 1-866-416-2366

Labeling

B-PL035 Artwork

PRIVATE LABEL SPF 50 80 MIN WATER RESISTANT 
homosalate, octisalate, zinc oxide sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION165 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
C15-19 ALKANE (UNII: CI87N1IM01)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
GOSSYPIUM HIRSUTUM LEAF (UNII: 7S4U9R5259)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0035-11000 g in 1 TUBE; Type 0: Not a Combination Product12/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/2020
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0035)

Revised: 11/2023
Document Id: 6a3535ae-574f-48d8-bfc0-5b38f54c93ee
Set id: 8849fa88-24c8-410d-b16e-60da38288f98
Version: 4
Effective Time: 20231114
 
Swiss-American CDMO, LLC