DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate liquid 
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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Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50

Active Ingredients     Purpose

Avobenzone 3%      Sunscreen

Homosalate 4%      Sunscreen

Octinoxate 6%       Sunscreen

Octisalate 3%        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.

Keep out of reach of children

Stop use and ask a doctor if rash occurs

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

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 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

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

label

box

DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-133
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) HOMOSALATE4 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-133-021 in 1 BOX01/09/2015
1NDC:75936-133-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:75936-133-041 in 1 BOX01/09/2015
2NDC:75936-133-0330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3NDC:75936-133-061 in 1 BOX01/09/2015
3NDC:75936-133-0515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/09/2015
Labeler - Taylor James, LTD (033381850)
Registrant - Taylor James, LTD (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals140653770manufacture(75936-133)

Revised: 1/2017
Document Id: bb620cdd-d784-4a9b-b282-84c85d39618d
Set id: efe3f7b3-e0ca-4550-972d-a90f31f2295d
Version: 6
Effective Time: 20170123
 
Taylor James, LTD