THE MINERAL LIP ONE SPF 45 NOURISHING LIP TINT BERRY BALMY- zinc oxide lipstick

The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy by

Drug Labeling and Warnings

The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy 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 22.95%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

WARNINGS

Warnings

For external use only

Do not useon damaged or broken skin

Stop use and ask a doctor ifrash occurs

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

DIRECTIONS

Directions

• Apply generously to lips before sun exposure.
• Reapply frequently
• Do not swallow
• Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients

Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Pentaerythrityl Tetraisostearate, Diisostearyl Malate, Butyloctyl Salicylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyglyceryl-4 Isostearate, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Stearalkonium Hectorite, Flavor, Iron Oxides (Ci 77491), Titanium Dioxide (Ci 77891), Propylene Carbonate, Polyglycerin-3, Acacia Decurrens Flower Wax, Iron Oxides (Ci 77492), Red 28 Lake (Ci 45410), Dehydroacetic Acid, Iron Oxides (Ci 77499), Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Tocopherol

QUESTIONS OR COMENTS

Questions or comments?

1-888-426-0695. Monday-Friday, 9 a.m. - 5 p.m. EST

PRINCIPAL DISPLAY PANEL

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD 5.2g/.18oz

INGREDIENTS AND APPEARANCE

THE MINERAL LIP ONE SPF 45 NOURISHING LIP TINT BERRY BALMY 
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.95 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOSTEARIC ACID (UNII: X33R8U0062)
CI 45410 (UNII: 767IP0Y5NH)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONIC ACID (UNII: S270N0TRQY)
CI 77499 (UNII: XM0M87F357)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CI 77491 (UNII: 1K09F3G675)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
SILICA (UNII: ETJ7Z6XBU4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CI 77492 (UNII: EX438O2MRT)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-224-01	1 in 1 CARTON	10/01/2025
1		5.2 mL in 1 CARTRIDGE; 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(68577-224)