TRILIPIDERM PROTECTIVE DAY- homosalate, ethylhexyl methoxycinnamate,butyl methoxydibenzoylmethane, 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

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

Aqua (Purified Water), Squalane (Olive-Derived), Emulsifying Wax NF, Sodium Hyaluronate, Meadowfoam Delta Lactone, Limnanthes Alba (Meadowfoam) Seed Oil, Crambe Abyssinica Seed Oil, Olea Europea (Olive) Oil Unsaponifiables, Glycine Soja (Soybean) Oil and Retinyl Palmitate (and) Tocopherol Acetate (and) Ascorbyl Isostearate (Vitamins A, C, E), Cholecalciferol (Corn) Oil (Vitamin D3), Chamomilla Recutita Matricaria Flower Extract, Capryl Glycol (and) Caprylic Acid (and) Lauric Acid, Capryl Glycol (and) Caprylhydroxamic Acid (and) Glycerin, Carbomer

Other Information

• Protect this product from excessive heat and direct sun

TriLipiderm Protective Day Creme

.14oz. Label 1.7oz. Label Box Label

INGREDIENTS AND APPEARANCE

TRILIPIDERM  PROTECTIVE DAY
homosalate, ethylhexyl methoxycinnamate,butyl methoxydibenzoylmethane, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60892-602
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
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEADOWLACTONE (UNII: 3OY5Q13U9R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL ISOSTEARATE (UNII: 0833RLV6F6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAURIC ACID (UNII: 1160N9NU9U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SQUALANE (UNII: GW89575KF9)
SOYBEAN OIL (UNII: 241ATL177A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
OLIVE OIL (UNII: 6UYK2W1W1E)
CHAMOMILE (UNII: FGL3685T2X)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CAPRYLIC ACID (UNII: OBL58JN025)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60892-602-33	1 in 1 BOX	12/12/2018
1	NDC: 60892-602-32	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 60892-602-77	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	12/12/2018

Labeler - TriLipid Research Institute, LLC (013903326)

Establishment
Name	Address	ID/FEI	Business Operations
Paket Corporation		007774730	pack(60892-602)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(60892-602)