Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50

Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50

Drug Labeling and Warnings

Drug Details

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DEFENSE REFRESH SETTING 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 2.8%   Sunscreen

Homosalate 9.8%    Sunscreen

Octisalate 4.9%       Sunscreen

Octocrylene 9.5%    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.

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

When using this product keep out of eyes

Rinse with water to remove

Directions

Apply generously and evenly15 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 early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m.-2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Reapply at least every 2 hours

  • Children under 6 months: Ask a doctor

Inactive Ingredients Alcohol Denat., Bisabolol, Brassica Compestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl syringlidenemalonate, Diheptyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate

Supergoop!

Defense (RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SPF 40

Water and Sweat Resistant (40 minutes)

Defense Refresh SPF 40 OL

DEFENSE REFRESH SETTING MIST BROAD SPECTRUM SUNSCREEN SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75936-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 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)  
LEVOMENOL (UNII: 24WE03BX2T)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
ETHYL FERULATE (UNII: 5B8915UELW)  
LAUROYL LYSINE (UNII: 113171Q70B)  
NYLON-12 (UNII: 446U8J075B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75936-134-0115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2020
2NDC: 75936-134-0230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2020
3NDC: 75936-134-03100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2020
Labeler - Taylor James, LTD (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals140653770manufacture(75936-134)

Revised: 1/2017
 
Taylor James, LTD


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