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TriLipiderm

TriLipid Research Institute, LLC

TriLipiderm Broad Spectrum SPF 30


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Butyl Methoxydibenzoylmethane 3%, Ethylhexyl Methoxycinnamate 7.5%, Homosalate 10%, Octocrylene 2.7%

Purpose

Sunscreen

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 the sun

Warnings

For External Use Only

Do Not Use

on Damaged or Broken Skin

Stop Use and Ask a Doctor

If Rash Occurs

When Using This Product

Keep Out Of Eyes. Rinse with water to remove

Keep Out of Reach of Children.

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

Directions:

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor
  • 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 10:00 AM – 2:00 PM
  • Wear long sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Purified water, Helianthus Annuus (Sunflower) Seed Oil, CetearylAlcohol, Limnanthes Alba (Meadowfoam) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Crambe Abyssinica Seed Oil, Olea Europaea (Olive) Oil Unsaponifiables, Vitamin D, Calendula officinalis flower extract, Chamomilla Recutita Matricaria flower extract, Phenoxyethanol and Caprylyl Alcohol and Ethylhexyl Glycerin and Hexylene Glycol, Meadowfoam Estolide, Panthenol, Beta-Sitosterol, Meadowfoam Delta-Lactone, Tocopherol, Polysorbate 65, Triethanolamine, Carbomer, PEG-40 Hydrogenated Castor Oil, Meadowfoamamidopropyl Betaine, Dimethicone PEG-8 Meadowfoamate, O-Cymen-5-OL, Fragrance

Other Information

  • Protect this product from excessive heat and direct sun

Made in the USA * Distributed by:

Trilipid Research Institute LLC

Jackson, WY 83002

Trilipiderm Broad Spectrum SPF 30Labels64oz, 8oz, 3oz, 0.3oz

64oz labelTriLipiderm 8oz labelTriLipiderm 3oz labelTriLipiderm 0.3oz labelTriLipiderm

TriLipiderm

Butyl Methoxydibenzoylmethane, Ethylhexyl methoxycinnamate, Homosalate, Octocrylene CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:60892-601
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 3 g
OCTINOXATE OCTINOXATE 7.5 g
HOMOSALATE Homosalate 10 g
OCTOCRYLENE Octocrylene 2.7 g

Inactive Ingredients

Ingredient Name Strength
water
SUNFLOWER OIL
CETOSTEARYL ALCOHOL
MEADOWFOAM SEED OIL
SAFFLOWER OIL
Jojoba Oil
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL
olive oil
Vitamin D
CALENDULA OFFICINALIS FLOWER
CHAMOMILE
PHENOXYETHANOL
CAPRYLIC ALCOHOL
ETHYLHEXYLGLYCERIN
Hexylene Glycol
PANTHENOL
SODIUM BETA-SITOSTERYL SULFATE
Tocopherol
POLYSORBATE 65
TROLAMINE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
PEG-40 CASTOR OIL
O-CYMEN-5-OL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60892-601-64 1896 in 1 BOTTLE, PUMP
2 NDC:60892-601-32 948 in 1 BOTTLE, PUMP
3 NDC:60892-601-08 237 in 1 BOTTLE, PUMP
4 NDC:60892-601-03 89 in 1 TUBE
5 NDC:60892-601-01 29.625 in 1 TUBE
6 NDC:60892-601-00 9 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-01-31


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