SUN PROTECT LIP BALM SPF 30- zinc oxide and titanium dioxide cream 
Stream2Sea, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sun Protected Lip Balm SPF 30 +

Drug Facts

Active ingredients

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

Purpose
Sunscreen

Uses

Warnings

Directions

Other information

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 NATURALLY NAKED - Label

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

SUN PROTECT LIP BALM CUCUMBER MINT - Label

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

SUN PROTECT LIP BALM CHERRY VANILLA - Label
SUN PROTECT LIP BALM SPF 30 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE280 mg  in 4 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE240 mg  in 4 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINT (Cucumber Mint) , CHERRY (Cherry Vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69555-036-044 g in 1 TUBE; Type 0: Not a Combination Product07/10/2021
2NDC:69555-036-054 g in 1 TUBE; Type 0: Not a Combination Product07/10/2021
3NDC:69555-036-064 g in 1 TUBE; Type 0: Not a Combination Product07/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/10/2021
Labeler - Stream2Sea, LLC (052920828)
Registrant - Stream2Sea, LLC (052920828)
Establishment
NameAddressID/FEIBusiness Operations
Stream2Sea, LLC052920828manufacture(69555-036)

Revised: 1/2023
Document Id: f21e2f96-6c05-fbe5-e053-2995a90a3948
Set id: 21386652-b952-48be-b077-1acecc7f0eb0
Version: 2
Effective Time: 20230112
 
Stream2Sea, LLC