Drug Facts

Active Ingredients

Homosalate 10% Octinoxate 7.5% Avobenzone 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 againg caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin.

Stop use and ask 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 • 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 the time in the sun, especially from 10:00 AM - 2:00 PM • Wear long sleeved shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Butylene Glycol, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Oil, Caprylyl Glycol, Ceteareth-20, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin B3), Crambe Abyssinica (Abyssinian) Oil, Dodecane, Gluconolactone, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Hexylene Glycol, Limnanthes Alba (Meadowfoam) Oil, Magnesium Aluminum Silicate, Meadowfoam Estolide, o-Cymen-5-ol, Olea Europaea (Olive) Fruit Unsaponifiables, dl-Panthenol, Partum (Fragrance), Phenoxyethanol, Phytosterols, Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Oil, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum.

Other Information

• Protect this product from excessive heat and direct sun

Package Labeling:

Label

TRILIPIDERM ALL-BODY MOISTURE RETENTION CREAM SPF-30
homosalate, octinoxate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60892-605
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SAFFLOWER (UNII: 4VBL71TY4Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CHAMOMILE (UNII: FGL3685T2X)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DODECANE (UNII: 11A386X1QH)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MEADOWFOAM ESTOLIDE (UNII: 3HH93SL2H9)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
GREEN OLIVE (UNII: 6HD2W46UEG)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60892-605-00	89 mL in 1 TUBE; Type 0: Not a Combination Product	07/03/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/03/2023

Labeler - Trilipid Research Institute, LLC (013903326)

TRILIPIDERM All-Body Moisture Retention Cream SPF-30