SUN PROTECT LIP BALM SPF 30- zinc oxide and titanium dioxide cream

SUN PROTECT LIP BALM SPF 30 by

Drug Labeling and Warnings

SUN PROTECT LIP BALM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients

Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

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.

WARNINGS

Warnings

• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product, keep out of eyes. Rinse with water to remove.
• Keep out of reach of children, If swallowed, get medical help or contact a poison control centre right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
• For children under 6 months of age; ask a doctor.

OTHER SAFETY INFORMATION

Other information

• This is a personal care item, and should be used by one individual only.
• Protect this product from excessive heat and direct sun.
• Do not use if safety seal is broken prior to purchase.

INACTIVE INGREDIENT

Inactive ingredients

Sun Protected Lip Balm SPF 30 + - Naturally Naked

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea) Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifers (Carnuba) Wax, Cetyl Esters, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter.

Sun Protected Lip Balm SPF 30 + - Cherry Vanilla

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa(Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl esters, Cherry Vanilla Flavor* Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.
*Flavor is certified all natural.

Sun Protected Lip Balm SPF 30 + - Cucumber Mint

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil , Candelilla Cera wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl Esters, Cucumber Mint Flavor* Glyceryl Caprylate, Helianthus Annuus(Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.
*Flavor is certified all natural.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUN PROTECT LIP BALM NATURALLY NAKED SPF 30 + 0.15 OZ - Label - NDC - 69555-036-01

SUN PROTECT LIP BALM CUCUMBER MINT SPF 30 + 0.15 OZ - Label - NDC - 69555-036-02

SUN PROTECT LIP BALM CHERRY VANILLA SPF 30 + 0.15 OZ - Label - NDC - 69555-036-03

INGREDIENTS AND APPEARANCE

SUN PROTECT LIP BALM SPF 30 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	280 mg  in 4 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	240 mg  in 4 g

Inactive Ingredients
Ingredient Name	Strength
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CANDELILLA WAX (UNII: WL0328HX19)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ESTERS WAX (UNII: D072FFP9GU)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STARCH, RICE (UNII: 4DGK8B7I3S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
COCOA BUTTER (UNII: 512OYT1CRR)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
HOLY BASIL LEAF (UNII: SCJ765569P)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Cucumber Mint) , CHERRY (Cherry Vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-036-04	4 g in 1 TUBE; Type 0: Not a Combination Product	07/10/2021
2	NDC: 69555-036-05	4 g in 1 TUBE; Type 0: Not a Combination Product	07/10/2021
3	NDC: 69555-036-06	4 g in 1 TUBE; Type 0: Not a Combination Product	07/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/10/2021

Labeler - Stream2Sea, LLC (052920828)

Registrant - Stream2Sea, LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(69555-036)