UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate cream 
TAYLOR JAMES, LTD.

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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Unseen Sunscreen Broad Spectrum SPF 40

Active Ingredients        Purpose

Avobenzone 3%          Sunscreen

Homosalate 8%          Sunscreen

Octinoxate 4.5%         Sunscreen

Octisalate 5%             Sunscreen

Uses

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

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on damaged or broken skin

Directions

after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Inactive Ingredients

Isododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Polyester-8,Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Diethylhexyl Syringylidenemalonate, Mannitol, Olibanum, Lecithin, Microcrystalline Cellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol

Unseen Sunscreen

Broad Spectrum SPF 40

Water and sweat resistant (40 minutes)

1.7 fl oz/ 50 ml

carton

inner

UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40 
avobenzone, homosalate, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
MANNITOL (UNII: 3OWL53L36A)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
ZINC SULFATE (UNII: 89DS0H96TB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-142-021 in 1 CARTON10/12/2017
1NDC:75936-142-0150 mL in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:75936-142-0615 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2017
3NDC:75936-142-0310 mL in 1 PACKAGE; Type 0: Not a Combination Product10/12/2017
4NDC:75936-142-045 mL in 1 PACKAGE; Type 0: Not a Combination Product10/12/2017
5NDC:75936-142-051.5 mL in 1 PACKAGE; Type 0: Not a Combination Product10/12/2017
6NDC:75936-142-0720 mL in 1 CARTON; Type 0: Not a Combination Product01/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/10/2017
Labeler - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Cosway Company Inc.052400223manufacture(75936-142)

Revised: 1/2021
Document Id: b83f9ea5-7273-cc9b-e053-2a95a90abd48
Set id: d8ac12f2-485c-4b28-847b-e12d034ee075
Version: 8
Effective Time: 20210106
 
TAYLOR JAMES, LTD.