ECOSTICK SUNSCREEN SPF 35- zinc oxide, titanium dioxide stick

EcoStick Sunscreen by

Drug Labeling and Warnings

EcoStick Sunscreen by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide (Non-Nano) 7%

Zinc Oxide (Non-Nano) 6%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

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.
• ​Stop use and ask a doctor ​if rash occurs.

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.

Directions

• Apply liberally on cleansed skin prior to sun exposure.
• 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 of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.

Inactive ingredients

Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum(Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa(Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic CapricTriglycerides, Helianthus Annuus (Sunflower) Seed Oil*,TheobromaCacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax,Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, GlycerylCaprylate, Silica, Mica, Mixed Tocopherols (Vitamin E).

WILD BLUE
Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa(Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax,Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Glyceryl Caprylate, Silica, Mica, Spirulina Platensis Extract (and) Trehalose, Mixed Tocopherols (Vitamin E).

WILD PINK
Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa (Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax, Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Rice Starch, Glyceryl Caprylate, Silica, Mica, Raphanus Sativus (Radish) Root Extract (and) Citric Acid (and) Maltodextrin, Mixed Tocopherols (Vitamin E).

TINTED
Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, and Olea Europa (Olive) Leaf in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax, Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Glyceryl Caprylate, Silica, Mica, Mixed Tocopherols (Vitamin E), Iron Oxides (C.I.77492, C.I. 77491, C.I. 77499) and Jojoba Esters

SUNSCREEN 4 KIDS
Extracts of Chamomilla Recutita (Chamomile) Flower* (and) Calendula Officinalis* (and) Camellia Sinensis (Green Tea) Leaf* (and) Ocimum Tenuiflorum (Tulsi) in Cocos Nucifera (Coconut) Oil*, Caprylic Capric Triglycerides, Helianthus Annuus (Sunflower) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Copernicia Prunifera (Carnauba) Wax, Candelilla Cera Wax, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter) Fruit, Cetyl Esters, Polyhydroxystearic Acid, Rice Starch, Glyceryl Caprylate, Silica, Mica, Mixed Tocopherols (Vitamin E).

Other information

Protect this product from excessive heat and direct sun.

Questions or comments?

call 1.863.473.4223 or visit www.stream2sea.com

PRINCIPAL DISPLAY PANEL

EcoStick Sport Sunscreen Carton Label

EcoStick Sport Sunscreen Container Label

EcoStick Sport Screenscreen Wild Blue Carton Label

EcoStick Sport Screenscreen Wild Blue Container Label

EcoStick Sport Screenscreen Tint Carton Label

EcoStick Sport Screenscreen Tint Container Label

EcoStick Sport Screenscreen Wild Pink Carton Label

EcoStick Sport Screenscreen Wild Pink Container Label

EcoStick Sport Screenscreen 4 Kids Carton Label

EcoStick Sport Screenscreen 4 Kids Container Label

INGREDIENTS AND APPEARANCE

ECOSTICK SUNSCREEN   SPF 35
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HOLY BASIL LEAF (UNII: SCJ765569P)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CETYL ESTERS WAX (UNII: D072FFP9GU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STARCH, RICE (UNII: 4DGK8B7I3S)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
TREHALOSE (UNII: B8WCK70T7I)
RADISH (UNII: EM5RP35463)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Product Characteristics
Color	blue (WILD BLUE) , pink (WILD PINK)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-035-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	02/15/2021
2	NDC: 69555-035-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	02/15/2021
3	NDC: 69555-035-03	15 mL in 1 TUBE; Type 0: Not a Combination Product	02/15/2021
4	NDC: 69555-035-04	15 mL in 1 TUBE; Type 0: Not a Combination Product	02/15/2021
5	NDC: 69555-035-05	15 mL in 1 TUBE; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/15/2021

Labeler - Stream2Sea, LLC (052920828)

Registrant - Stream2Sea, LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(69555-035)