SUNNYSCREEN SPF 50 STICK- zinc oxide stick

Sunnyscreen SPF 50 Stick by

Drug Labeling and Warnings

Sunnyscreen SPF 50 Stick 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 21% 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 or irritation develops and lasts.

WARNINGS

Warnings

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

For external use only

DOSAGE & ADMINISTRATION

Directions

Apply generously and evenly 15 minutes before sun exposure and at least
every 2 hours.

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 Beeswax, Bertholletia Excelsa Seed Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Linum Usitassimum (Lineseed) Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Oryzanol, Salvia hispanica (Chia) Seed Oil, SImmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao(Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract

PRINCIPAL DISPLAY PANEL

Sunnyscreen

SPF 50 Stick for babies + kiddos

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 minutes)

0.7 oz. / 19.8g

INGREDIENTS AND APPEARANCE

SUNNYSCREEN SPF 50 STICK 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
ORYZANOL (UNII: SST9XCL51M)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
LEVOMENOL (UNII: 24WE03BX2T)
CHIA SEED OIL (UNII: MC2LH51BO7)
CANDELILLA WAX (UNII: WL0328HX19)
VANILLA (UNII: Q74T35078H)
LINSEED OIL (UNII: 84XB4DV00W)
BRAZIL NUT OIL (UNII: 0G89T29HO6)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-251-01	79.8 g in 1 BOX; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2019

Labeler - TAYLOR JAMES, LTD (033381850)

Registrant - TAYLOR JAMES, LTD (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(75936-251)