Label: BUILDABLE BLUR CC BROAD SPECTRUM SPF 40 SUNSCREEN- homosalate, octisalate, and zinc oxide cream
- NDC Code(s): 77365-005-01
- Packager: Thrive Causemetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 31, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk Skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
For sunscreen use:
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
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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:
- Limit time in the sun, especially from 10 am. - 2 pm.
- Wear long-sleeved shirts, pants, and sunglasses.
- Children under 6 months of age: Ask a doctor.
- Other information
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Inactive ingredients
AQUA/WATER/EAU, DIMETHICONE, BUTYLOCTYL SALICYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, PENTYLENE GLYCOL, SODIUM CHLORIDE, TRIBEHENIN, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, PHENYL TRIMETHICONE, TETRAHEXYLDECYL ASCORBATE, LINUM USITATISSIMUM (LINSEED) SEED EXTRACT, DICAPRYLYL CARBONATE, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL METHICONE, DIMETHICONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, ALUMINUM HYDROXIDE, MICA, QUATERNIUM-90 BENTONITE, SODIUM PHYTATE, PROPYLENE CARBONATE, HYDROXYACETOPHENONE, CAPRYLYL GLYCOL, [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, 77492, 77499), ULTRAMARINES (CI 77007)].
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Box
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INGREDIENTS AND APPEARANCE
BUILDABLE BLUR CC BROAD SPECTRUM SPF 40 SUNSCREEN
homosalate, octisalate, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77365-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 90 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 45 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 78 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIBEHENIN (UNII: 8OC9U7TQZ0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) FLAX SEED (UNII: 4110YT348C) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ETHYLHEXYL PALMITATE (UNII: 2865993309) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MICA (UNII: V8A1AW0880) QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C) PHYTATE SODIUM (UNII: 88496G1ERL) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ULTRAMARINE BLUE (UNII: I39WR998BI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77365-005-01 1 in 1 BOX 09/07/2022 1 30 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 FINAL part352 09/07/2022 Labeler - Thrive Causemetics (039299574) Establishment Name Address ID/FEI Business Operations COSMAX USA INC. (COSMAX USA, CORPORATION) 010990210 MANUFACTURE(77365-005)
