UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate cream

Unseen Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Unseen Sunscreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Cosway Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients        Purpose

Avobenzone 3%          Sunscreen

Homosalate 8%          Sunscreen

Octinoxate 4.5%         Sunscreen

Octisalate 5%             Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

DOSAGE & ADMINISTRATION

Directions

• apply generously and evenly 15 minutes before sun exposure
• reapply:

after 40 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 value 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: ask a doctor

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Unseen Sunscreen

Broad Spectrum SPF 40

Water and sweat resistant (40 minutes)

1.7 fl oz/ 50 ml

INGREDIENTS AND APPEARANCE

UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40 
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-142-02	1 in 1 CARTON	10/12/2017
1	NDC: 75936-142-01	50 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 75936-142-06	15 mL in 1 TUBE; Type 0: Not a Combination Product	10/12/2017
3	NDC: 75936-142-03	10 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/12/2017
4	NDC: 75936-142-04	5 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/12/2017
5	NDC: 75936-142-05	1.5 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/10/2017

Labeler - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-142)