BUILDABLE BLUR CC BROAD SPECTRUM SPF 40 SUNSCREEN- homosalate, octisalate, and zinc oxide cream

Buildable Blur CC Broad Spectrum SPF 40 Sunscreen by

Drug Labeling and Warnings

Buildable Blur CC Broad Spectrum SPF 40 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Thrive Causemetics, COSMAX USA INC. (COSMAX USA, CORPORATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 9.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Zinc Oxide 7.8%	Sunscreen

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

• 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. If swallowed, get medical help or contact a Poison Control Center right away.

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.
• 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

• Protect this product in this container from excessive heat and direct sun.

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?

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

SPL UNCLASSIFIED SECTION

Dist. by Thrive Causemetics, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

thrive™
causemetics

buildable blur™
CC CREAM

Blur Effect Technology™

Broad Spectrum SPF 40
Sunscreen

1 fl oz / 30 mL

INGREDIENTS AND APPEARANCE

BUILDABLE BLUR CC BROAD SPECTRUM SPF 40 SUNSCREEN 
homosalate, octisalate, and zinc oxide cream

Product 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)