DEFENSE REFRESH SETTING MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate liquid

Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Taylor James, LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients   Purpose

Avobenzone 2.8%   Sunscreen

Homosalate 9.8%    Sunscreen

Octisalate 4.9%       Sunscreen

Octocrylene 9.5%    Sunscreen           

PURPOSE

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

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

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

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Supergoop!

Defense (RE) Setting Mist

SPF 40

Broad Spectrum Sunscreen SPF 40

Water and Sweat Resistant (40 minutes)

INGREDIENTS AND APPEARANCE

DEFENSE REFRESH SETTING MIST BROAD SPECTRUM SUNSCREEN SPF 50   SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.8 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-134-01	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2020
2	NDC: 75936-134-02	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2020
3	NDC: 75936-134-03	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2020

Labeler - Taylor James, LTD (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals		140653770	manufacture(75936-134)