Filtered Effects Protecting Primer Broad Spectrum Spf 37 Sunscreen Water Resistant (80 Minutes)
FDA Label NDC 77365-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Thrive Causemetics for the product Filtered Effects Protecting Primer Broad Spectrum Spf 37 Sunscreen Water Resistant (80 Minutes) (NDC 77365-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active ingredientsPurpose
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.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

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

Principal Display Panel (30 mL Tube Box)

Principal Display Panel (30 mL Tube Box)

* Please review the disclaimer below.