Tropic Sport Mineral Sunscreen by X3EM Brands LLC

Tropic Sport Mineral Sunscreen by

Drug Labeling and Warnings

Tropic Sport Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by X3EM Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TROPIC SPORT MINERAL SUNSCREEN SPF 50- titanium dioxide, zinc oxide cream 
X3EM Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Titanium Dioxide, 6.5%

Zinc Oxide, 16.5%

Sunscreen

Uses

 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

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 doctor if rash occur

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

Directions

 apply liberally 15 minutes before sun exposure

 reapply: after 80 minutes of swimming or sweating immediately after towel drying 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-sleeved shirts, pants, hats, and sunglasses

 children under 6 months of age: Ask a doctor

Other information

 protect the product in this container from excessive heat and direct sun

Inactive ingredients Water/Aqua/Eau, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Glycerin, Cetearyl Alcohol, Dimethicone, Steareth-2, Polyhydroxystearic Acid, Steareth-21, Silica, Aloe Barbadensis Leaf Extract, Camellia Oleifera Leaf Extract, Pleiogynium Timoriense Fruit Extract, Podocarpus Elatus Fruit Extract, Terminalia Ferdinandiana Fruit Extract, Astrocaryum Tucuma Seed Butter, Adansonia Digitata Seed Oil, Macadamia Ternifolia Seed Oil, Dipotassium Glycyrrhizate, Bisabolol, Propanediol, Stearic Acid, Alumina, Sodium Stearoyl Glutamate, Xanthan Gum, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Caprylyl Glycol, Fragrance (Parfum).

Questions or comments? Call 1-844-484-2096 or www.tropicsport.com

TSSPF50

TROPIC SPORT MINERAL SUNSCREEN  SPF 50
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70884-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.5 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARETH-2 (UNII: V56DFE46J5)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARETH-21 (UNII: 53J3F32P58)  
PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
MACADAMIA OIL (UNII: 515610SU8C)  
PROPANEDIOL (UNII: 5965N8W85T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70884-408-07192 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/201904/08/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/08/201904/08/2020
Labeler - X3EM Brands LLC (080315280)

Revised: 4/2019
 
X3EM Brands LLC