(RE)SETTING REFRESHING MIST SPF 40- avobenzone, homosalate, octisalate, octocrylene spray 
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.

----------

(Re)Setting Refreshing Mist SPF 40

Active ingredients Purpose

Avobenzone 2.9% Sunscreen

Homosalate 9.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% Sunscreen

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

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.

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 your time in the sun, especially from 10
a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

•Children under 6 months of age: ask a doctor.

Inactive ingredients:

Alcohol Denat., Bisabolol, Brassica Camprestris/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, Rosemarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate

Supergoop!

(Re) Setting Refreshing Mist

SPF 40

Broad Spectrum

Sunscreen SPF 40 PA+++

Water & Sweat Resistant (40 minutes)

3.4 fl. oz. / 100 ml.

Re setting refreshing mist SPF 40

(RE)SETTING REFRESHING MIST SPF 40 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-361
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ETHYL FERULATE (UNII: 5B8915UELW)  
LAUROYL LYSINE (UNII: 113171Q70B)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
SPEARMINT OIL (UNII: C3M81465G5)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
NYLON-12 (UNII: 446U8J075B)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ISODODECANE (UNII: A8289P68Y2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-361-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2022
2NDC:75936-361-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/05/2022
Labeler - Supergoop, LLC (117061743)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Inc967781555manufacture(75936-361)

Revised: 10/2022
Document Id: eaf5c020-1204-52e6-e053-2a95a90a3b3b
Set id: d4d8f28d-cb00-298d-e053-2995a90a10eb
Version: 2
Effective Time: 20221013
 
Supergoop, LLC