DEFENSE REFRESH (RE)SETTING MIST SPF 40- avobenzone, homosalate , octisalate, octocrylene liquid 
Supergoop LLC

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 (Re)Setting Mist SPF 40

Avobenzone 2.9%..............Sunscreen

Homosalate 9.8%.............Sunscreen

Octisalate 4.9%..................Sunscreen

Octocrylene 9.5%...............Sunscreen

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

Stop use and ask a doctor if rash occurs.

For external use only. Do not useon damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

· Shake well then 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

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

Protect the product in this contianer from excessive heat and direct sun.

Defense Refresh backSupergoop!

Defense Refresh

(RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SFP 40

Water & Sweat Resistant (40 minutes)

1.0 fl. oz. / 30 ml.

Defense Refresh front

DEFENSE REFRESH (RE)SETTING MIST SPF 40 
avobenzone, homosalate , octisalate, octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-354
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
ETHYL FERULATE (UNII: 5B8915UELW)  
ISODODECANE (UNII: A8289P68Y2)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SPEARMINT OIL (UNII: C3M81465G5)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
NYLON-12 (UNII: 446U8J075B)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
LEVOMENOL (UNII: 24WE03BX2T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-354-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/20/2021
Labeler - Supergoop LLC (117061743)

Revised: 5/2022
Document Id: de0c153a-2fcb-3a3c-e053-2995a90a59d4
Set id: b95ad8e3-978b-b721-e053-2a95a90a1e54
Version: 3
Effective Time: 20220502
 
Supergoop LLC