SPF 30 LIP BALM- titanium dioxide stick 
Malin and Goetz Inc

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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spf 30 Lip Balm

Active Ingredient Purpose

Titanium Dioxide 3.32% Sunscreen

Uses

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor

Warnings

For external use only

Do not use on damaged or broken skin

When using this product

Directions

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:

Other information

Inactive Ingredients

Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.

(Malin+Goetz)

spf 30 lip balm.

Broad Spectrum Mineral Sunscreen

Water Resistant 40 minutes

0.3fl. oz./10ml

lip balm carton

lip balm tube

SPF 30 LIP BALM 
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
EUGENOL (UNII: 3T8H1794QW)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
COUMARIN (UNII: A4VZ22K1WT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
URSOLIC ACID (UNII: P3M2575F3F)  
CINNAMALDEHYDE (UNII: SR60A3XG0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53634-129-0110 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/01/2023
Labeler - Malin and Goetz Inc (138615930)

Revised: 6/2023
Document Id: fe1b3122-b6e3-46fa-e053-6394a90afd59
Set id: fe1b3122-b6e2-46fa-e053-6394a90afd59
Version: 1
Effective Time: 20230614
 
Malin and Goetz Inc