DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate liquid

Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Taylor James, LTD, Bell Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients     Purpose

Avobenzone 3%      Sunscreen

Homosalate 4%      Sunscreen

Octinoxate 6%       Sunscreen

Octisalate 3%        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

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

When using this product keep out of eyes

Rinse with water to remove

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions Apply 15 minutes prior to sun exposure

Use a water resistant if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, Water

PRINCIPAL DISPLAY PANEL

Defense Refresh Setting Mist

With Rosemary

Broad Spectrum Sunscreen SPF 50

Matte finish three in one

sets make-up, controls oil and delivers UV photoaging protection

INGREDIENTS AND APPEARANCE

DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-133
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	4 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ISODODECANE (UNII: A8289P68Y2)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
ROSEMARY OIL (UNII: 8LGU7VM393)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-133-02	1 in 1 BOX	01/09/2015
1	NDC: 75936-133-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 75936-133-04	1 in 1 BOX	01/09/2015
2	NDC: 75936-133-03	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 75936-133-06	1 in 1 BOX	01/09/2015
3	NDC: 75936-133-05	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/09/2015

Labeler - Taylor James, LTD (033381850)

Registrant - Taylor James, LTD (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals		140653770	manufacture(75936-133)