Label: FILTERED EFFECTS PROTECTING PRIMER BROAD SPECTRUM SPF 37 SUNSCREEN WATER RESISTANT (80 MINUTES)- avobenzone, homosalate, and octisalate gel
- NDC Code(s): 77365-006-01
- 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 September 14, 2023
If you are a consumer or patient please visit this version.
- 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: after 80 minutes of swimming or sweating.
- immediately after towel drying.
- at least every 2 hours.
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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
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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Box
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INGREDIENTS AND APPEARANCE
FILTERED EFFECTS PROTECTING PRIMER BROAD SPECTRUM SPF 37 SUNSCREEN WATER RESISTANT (80 MINUTES)
avobenzone, homosalate, and octisalate gelProduct 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)
