FILTERED EFFECTS PROTECTING PRIMER BROAD SPECTRUM SPF 37 SUNSCREEN WATER RESISTANT (80 MINUTES)- avobenzone, homosalate, and octisalate gel

Filtered Effects Protecting Primer Broad Spectrum SPF 37 Sunscreen Water Resistant (80 minutes) by

Drug Labeling and Warnings

Filtered Effects Protecting Primer Broad Spectrum SPF 37 Sunscreen Water Resistant (80 minutes) by is a Otc medication manufactured, distributed, or labeled by Thrive Causemetics, Cosway Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 10.0%	Sunscreen
Octisalate 5.0%	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: after 80 minutes of swimming or sweating.
• immediately after towel drying.
• at least every 2 hours.
• 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 from excessive heat and direct sun.

Inactive ingredients

ISODODECANE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER, POLYESTER-7, NEOPENTYL GLYCOL DIHEPTANOATE, POLYESTER-8, DICAPRYLYL CARBONATE, POLYMETHYLSILSESQUIOXANE, VP/EICOSENE COPOLYMER, POLYHYDROXYSTEARIC ACID, NELUMBO NUCIFERA FLOWER EXTRACT, NYMPHAEA CAERULEA FLOWER EXTRACT, HYDROLYZED SODIUM HYALURONATE, PANTHENYL ETHYL ETHER, MUSA SAPIENTUM (BANANA) FLOWER EXTRACT, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TRIMETHYLSILOXYSILICATE, DIMETHICONE, DIETHYLHEXYL SYRINGYLIDENEMALONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, SPIRULINA MAXIMA EXTRACT, WATER (AQUA), ORYZA SATIVA (RICE) STARCH, CAPRYLYL GLYCOL, TITANIUM DIOXIDE (CI 77891)

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

filtered
effects™

PROTECTING PRIMER

SPF
37

Hydro Reset Solution™

Broad Spectrum SPF 37 Sunscreen
Water Resistant (80 minutes)

1 fl oz / 30 mL

INGREDIENTS AND APPEARANCE

FILTERED EFFECTS PROTECTING PRIMER BROAD SPECTRUM SPF 37 SUNSCREEN WATER RESISTANT (80 MINUTES) 
avobenzone, homosalate, and octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77365-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
NYMPHAEA CAERULEA FLOWER (UNII: S9560USZ74)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B)
MUSA X PARADISIACA FLOWER (UNII: DG5B0M0NGY)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SAFFLOWER OIL (UNII: 65UEH262IS)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
WATER (UNII: 059QF0KO0R)
STARCH, RICE (UNII: 4DGK8B7I3S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77365-006-01	1 in 1 BOX	04/19/2023
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	04/19/2023

Labeler - Thrive Causemetics (039299574)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company, Inc.		052400223	MANUFACTURE(77365-006)