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

Defense Refresh (Re)Setting Mist SPF 40 by

Drug Labeling and Warnings

Defense Refresh (Re)Setting Mist SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

PURPOSE

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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

DOSAGE & ADMINISTRATION

· 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

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

Supergoop!

Defense Refresh

(RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SFP 40

Water & Sweat Resistant (40 minutes)

1.0 fl. oz. / 30 ml.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-354-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/20/2021

Labeler - Supergoop LLC (117061743)