PRIME PROMETICS LIPOIL SPF 35 WARM SIENNA- zinc oxide oil

PRIME Prometics LipOil SPF 35 Warm Sienna by

Drug Labeling and Warnings

PRIME Prometics LipOil SPF 35 Warm Sienna by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 13.5%

PURPOSE

Purpose

Sunscreen

USES

Uses

• Helps prevent sunburn
• I 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

WARNINGS

• For external use only

• Do not useon damaged or broken skin

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

Stop use and ask doctorif rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

DIRECTIONS

• Apply generously and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months:

Ask doctor.

OTHER INFORMATION

OTHER INFORMATION

Protect Product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, SilicaDimethyl Silylate, Bis-DiglycerylPolyacyladipate-2, SorbitanOlivate, lsononyl lsononanoate, Sorbitanlsostearate, lsostearic Acid, Lecithin, Polyglyceryl-3Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, IronOxides (Cl 77491), TitaniumDioxide (Cl 77891), Iron Oxides (Cl 77492), Flavor, Menthone GlycerinAcetal, Iron Oxides (Cl 77499), Dehydroacetic Acid, Red 7 Lake (Cl 15850), Rosa Canina Seed Oil, Mangifera lndica (Mango) Seed Butter, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, and Tocopherol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIME PROMETICS LIPOIL SPF 35 WARM SIENNA 
zinc oxide oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
CI 77491 (UNII: 1K09F3G675)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ISOSTEARIC ACID (UNII: X33R8U0062)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MANGIFERA INDICA (MANGO) SEED BUTTER (UNII: 4OXD9M35X2)
HYALURONIC ACID (UNII: S270N0TRQY)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CI 77499 (UNII: XM0M87F357)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TOCOPHEROL (UNII: R0ZB2556P8)
MENTHONE GLYCERIN ACETAL (UNII: 7QQ1EE6RCP)
CI 77492 (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CI 15850 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-225-01	1 in 1 CARTON	10/01/2025
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2025

Labeler - COSMAX USA, CORP (010990210)

Registrant - COSMAX USA, CORP (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORP		010990210	manufacture(68577-225)