BRUSH ON BLOCK NUDE TINT PROTECTIVE LIP OIL BROAD SPECTRUM SPF 32- titanium dioxide, zinc oxide liquid

Brush on Block Nude Tint Protective Lip Oil Broad Spectrum SPF 32 by

Drug Labeling and Warnings

Brush on Block Nude Tint Protective Lip Oil Broad Spectrum SPF 32 by is a Otc medication manufactured, distributed, or labeled by SPF Ventures, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Titanium Dioxide 4.5%

Zinc Oxide 3.4%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If issued as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor   
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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-sleeve shirt, pants, hats, and sunglasses

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

Inner label   

INGREDIENTS AND APPEARANCE

BRUSH ON BLOCK NUDE TINT PROTECTIVE LIP OIL BROAD SPECTRUM SPF 32 
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58274-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58274-008-01	1 in 1 CARTON	02/01/2019
1		6.8 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2019

Labeler - SPF Ventures, LLC (055483891)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(58274-008)