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

(Re)Setting Refreshing Mist SPF 40 by

Drug Labeling and Warnings

(Re)Setting Refreshing Mist SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Bell International Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

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 product is 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 use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

• 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 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Supergoop!

(Re) Setting Refreshing Mist

SPF 40

Broad Spectrum

Sunscreen SPF 40 PA+++

Water & Sweat Resistant (40 minutes)

3.4 fl. oz. / 100 ml.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-361
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-361-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2022
2	NDC: 75936-361-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/05/2022

Labeler - Supergoop, LLC (117061743)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Inc		967781555	manufacture(75936-361)