MINERAL SUNSCREEN STICK SPF 50 SUPERGOOP- zinc oxide stick

Mineral Sunscreen Stick SPF 50 by

Drug Labeling and Warnings

Mineral Sunscreen Stick 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

​Zinc Oxide 17% ............... 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

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

DOSAGE & ADMINISTRATION

​Directions

• Apply liberally to face and body at least 15 minutes prior to sun exposure
• Reapply after 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Chlidren under 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 take other sun protection measures including:

• Limit time in the sun, especially from 10a.m.-2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients

Beeswax, Bisabolol,

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Jojoba Esters, Linum Usitatissimum (Linseed) Seed Oil, Octyldodecyl Oleate, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Salvia Hispanica (Chia) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cocao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract

PRINCIPAL DISPLAY PANEL

Supergoop

SPF  50

Water resistant (80 minutes)

100% Mineral Sunscreen Stick

With Avocado Oil

Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN STICK SPF 50  SUPERGOOP
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANDELILLA WAX (UNII: WL0328HX19)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
LINSEED OIL (UNII: 84XB4DV00W)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
BLACK OLIVE (UNII: 2M6QWV94OC)
OLIVE OIL (UNII: 6UYK2W1W1E)
GAMMA ORYZANOL (UNII: SST9XCL51M)
AVOCADO OIL (UNII: 6VNO72PFC1)
CHIA SEED OIL (UNII: MC2LH51BO7)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-511-01	18.9 g in 1 TUBE; Type 0: Not a Combination Product	08/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/14/2017

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(75936-511)