Label: BRUSH ON BLOCK NUDE TINT PROTECTIVE LIP OIL BROAD SPECTRUM SPF 32- titanium dioxide, zinc oxide liquid
- NDC Code(s): 58274-008-01
- Packager: SPF Ventures, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 7, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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INGREDIENTS AND APPEARANCE
BRUSH ON BLOCK NUDE TINT PROTECTIVE LIP OIL BROAD SPECTRUM SPF 32
titanium dioxide, zinc oxide liquidProduct 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)
