PHYSICAL SUNSCREEN SPF50 80 MIN WR 159-100- titanium dioxide, titanium dioxide sunscreen lotion 
Swiss-American CDMO, LLC

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Physical Sunscreen SPF50 80 min WR 159-100

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

Titanium Dioxide 4.23% Sunscreen
Zinc Oxide 18.28% 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 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.

Keep out of reach of children

Keep out of reach of children

Inactive ingredients

Water, C15-19 Alkane, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Hydrogenated Polyisobutene, Polyhydroxystearic Acid, Sodium Chloride, Triethoxycaprylylsilane, Silica, Saccharide Isomerate, Hydroxyacetophenone, Niacinamide, Sorbitan Olivate, Glyceryl Behenate, 1,2-Hexanediol, Caprylyl Glycol, Tocopheryl Acetate, Disodium EDTA, Scenedesmus Rubescens Extract, Gellan Gum, Polygonum Aviculare Extract, citric acid, sodium citrate, potassium sorbate, sodium benzoate

Other information

Protect this product from excessive heat and direct sun.

Questions

Call toll free 1-866-416-2366

Labeling

PL041 Drug Facts

PHYSICAL SUNSCREEN SPF50 80 MIN WR 159-100 
titanium dioxide, titanium dioxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42.3 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION182.8 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C15-19 ALKANE (UNII: CI87N1IM01)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
POLYGONUM AVICULARE WHOLE (UNII: M990N03611)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0044-190 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(60232-0044)

Revised: 11/2023
Document Id: 6943f1b5-dc1d-49af-a51e-4c4bb778c45b
Set id: 0cca7b65-e24a-429c-b157-5f4e343424ab
Version: 2
Effective Time: 20231109
 
Swiss-American CDMO, LLC