100% MINERAL BODY MIST WITH GREEN TEA EXTRACT BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide liquid

100% Mineral Body Mist With Green Tea Extract Broad Spectrum SPF 50 by

Drug Labeling and Warnings

100% Mineral Body Mist With Green Tea Extract Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Titanium Dioxide 10% Sunscreen

Zinc Oxide 12% 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

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Do not use in the presence of a flame or spark or while smoking.

Do not use on damaged or broken skin

When using this product, keep away from face to avoid breathing it. Keep out of eyes

Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

SHAKE WELL to activate, if the mist is clear, keep shaking.

• spray generously and spread evenly by hand 15 minutes before sun exposure
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face
• reapply:
• After 80 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

Aqua (Deionized Water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

PRINCIPAL DISPLAY PANEL

Supergoop!

PLAY

SPF 50

100% Mineral Body Mist

With Green Tea Extract

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 minutes)

6 fl. oz. / 177 ml.

INGREDIENTS AND APPEARANCE

100% MINERAL BODY MIST WITH GREEN TEA EXTRACT BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT (UNII: L56Z1JK48B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-212-01	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2020

Labeler - Taylor James, Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(75936-212)