MINERAL SUNSCREEN SPF 30- zinc oxide spray

Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Mineral Sunscreen SPF 30 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

Zinc Oxide 12.0% ..................................... Sunscreen

PURPOSE

​Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Sun Protection Mesusres), 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

INDICATIONS & USAGE

Stop use and ask a doctor is rash occurs

WARNINGS

​Warnings

• Flammable. Keep away from flames and sparks
• 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
• If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

​Directions

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

• Apply liberally 15 minutes before sun exposure
• Reapply:

     - after 80 minutes of swimming or sweating

     - immediately after towel drying

     - at least every 2 hours whem exposed to sunlight

•    Children un 6 months: Ask a doctor

​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 epsecially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Bentonite, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco Glucoside, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Undecylenate, Jojoba Esters, Melissa Officinalis Leaf Extract, Methyl Dihydroabietate, Nasturtium Officinale Flower/Leaf Extract, Spiraea Ulmaria Flower Extract, Water

PRINCIPAL DISPLAY PANEL

SPF 30 Water resistant (80 minutes)

100% Mineral

Sunscreen mist with Marigold Extract

Broad Spectrum SPF 30

6 fl. oz. / 177 mL.

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 30 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENTONITE (UNII: A3N5ZCN45C)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
COCO GLUCOSIDE (UNII: ICS790225B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-510-01	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/15/2017

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(75936-510)