BUILDABLE BLUR- homosalate, octisalate, zinc oxide cream

Buildable Blur by

Drug Labeling and Warnings

Buildable Blur by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 9.0%

Octisalate 4.5%

Zinc Oxide 7.8%

PURPOSE

Purpose

Sunscreen

USES

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun

WARNINGS

Warnings

For external use only.

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

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

DIRECTIONS

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
• Children under 6 months of age: 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 Broad Spectrum SPF value 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 shirts, pants, hats, and sunglasses.

OTHER INFORMATION

Other information

Protect the product in this container from excessive heat and direct sun

QUESTIONS

Questions?Call (888) 804-4318 or visit www.thrivecausemetics.com

INACTIVE INGREDIENT

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)].

Primary Package

Primary Package

Secondary Package

Outer Package

INGREDIENTS AND APPEARANCE

BUILDABLE BLUR 
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.8 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
FLAX SEED (UNII: 4110YT348C)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
PHYTATE SODIUM (UNII: 88496G1ERL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ULTRAMARINE BLUE (UNII: I39WR998BI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-127-01	1 in 1 CARTON	12/01/2022
1		30 mg 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 Drug	M020	12/01/2022

Labeler - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-127)