TRILIPIDERM BROAD SPECTRUM SPF 30- butyl methoxydibenzoylmethane, ethylhexyl methoxycinnamate, homosalate, octocrylene cream

TriLipiderm by

Drug Labeling and Warnings

TriLipiderm by is a Otc medication manufactured, distributed, or labeled by TriLipid Research Institute, LLC, Paket Corporation, RNA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, Cetearyl Alcohol, 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

SPL UNCLASSIFIED SECTION

Made in the USA * Distributed by:

Trilipid Research Institute LLC

Jackson, WY 83002

Trilipiderm Broad Spectrum SPF 30 Labels 64oz, 8oz, 3oz, 0.3oz, 0.14oz

64oz label 8oz label 3oz label 0.3oz label

Box

.14oz. label 3oz. Label 3 oz Box

INGREDIENTS AND APPEARANCE

TRILIPIDERM  BROAD SPECTRUM SPF 30
butyl methoxydibenzoylmethane, ethylhexyl methoxycinnamate, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60892-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM BETA-SITOSTERYL SULFATE (UNII: I289C8TPSV)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYSORBATE 65 (UNII: 14BGY2Y3MJ)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
SAFFLOWER OIL (UNII: 65UEH262IS)
JOJOBA OIL (UNII: 724GKU717M)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
OLIVE OIL (UNII: 6UYK2W1W1E)
VITAMIN D (UNII: 9VU1KI44GP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
MEADOWLACTONE (UNII: 3OY5Q13U9R)
MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60892-601-64	1896 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/31/2014
2	NDC: 60892-601-32	948 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/31/2014
3	NDC: 60892-601-04	1 in 1 BOX	01/31/2014
3	NDC: 60892-601-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC: 60892-601-05	1 in 1 BOX	12/13/2018
4	NDC: 60892-601-03	89 mL in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 60892-601-01	29.625 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2014
6	NDC: 60892-601-00	9 mL in 1 PACKET; Type 0: Not a Combination Product	01/31/2014
7	NDC: 60892-601-77	4 mL in 1 PACKET; Type 0: Not a Combination Product	12/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/31/2014

Labeler - TriLipid Research Institute, LLC (013903326)

Establishment
Name	Address	ID/FEI	Business Operations
Paket Corporation		007774730	pack(60892-601)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(60892-601)