BRUSH ON BLOCK NUDE TINT PROTECTIVE LIP OIL BROAD SPECTRUM SPF 32- titanium dioxide, zinc oxide liquid 
SPF Ventures, 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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Brush on Block Nude Tint Protective Lip Oil

Active Ingredient

Titanium Dioxide 4.5%

Zinc Oxide 3.4%

Purpose

Sunscreen

Uses

Warnings

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

Directions

Other information

Protect this product from excessive heat and direct sun

Questions or Comments? Call toll free 1-800-916-7690

Inactive ingredients

Alumina, Argania Spinosa Kernel Oil, Bisabolol, Butylene/Ethylene/Styrene Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citrus Reticulata (Tangerine) Peel Oil, Ethylene/Propylene/Styrene Copolymer, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polyisobutene, Iron Oxides, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Stearic Acid, Tocopheryl Acetate

Package Label - Principal Display Panel

Carton Label

Carton label

Inner label   

Inner label

BRUSH ON BLOCK NUDE TINT PROTECTIVE LIP OIL BROAD SPECTRUM SPF 32 
titanium dioxide, zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58274-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE45 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARGAN OIL (UNII: 4V59G5UW9X)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MANDARIN OIL (UNII: NJO720F72R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CASTOR OIL (UNII: D5340Y2I9G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58274-008-011 in 1 CARTON02/01/2019
16.8 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2019
Labeler - SPF Ventures, LLC (055483891)
Establishment
NameAddressID/FEIBusiness Operations
Bentley Laboratories, LLC068351753manufacture(58274-008)

Revised: 7/2022
Document Id: ba18921b-1f2d-4f1c-b232-76ec2d554314
Set id: 0210a2db-ae0f-42df-898d-c60107154f87
Version: 4
Effective Time: 20220707
 
SPF Ventures, LLC