TINTED LIP CREAM SPF 15- zinc oxide cream

Tinted Lip Cream SPF 15 by

Drug Labeling and Warnings

Tinted Lip Cream SPF 15 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 9.82%

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 aging caused by the sun.

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

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

DIRECTIONS

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • use a water resistant sunscreen if swimming or sweating
  • 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m.- 2p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses

INACTIVE INGREDIENT

Inactive ingredients:

Hydrogenated Polydecene, Diisostearyl Malate, Ozokerite, Synthetic Wax, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Butyloctyl Salicylate, Tridecyl Trimellitate, Bis-Diglyceryl Polyacyladipate-2, Pentaerylhrityl Tetraisostearate, Polyglyceryl-4 Isostearate, Dimer Dilinoleyl Dimer Dilinoleate, Diglyceryl Sebacate/lsopalmitate*, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Caprae Lac (Goat Milk), Tocopherol (Vitamin E), Kaolin, Hydrogenated Vegetable Oil, Quercetin, Oleic/Linoleic/Linolenic Polyglycerides, Poly C10-30 Alkyl Acrylate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-2 Triisostearate, Stearalkonium Hectorite, Propylene Carbonate, Dehydroacetic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Iron Oxides (CI 77492), Titanium Dioxide (CI 77891), Carmine (CI 75470).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED LIP CREAM SPF 15 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.28 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
KAOLIN (UNII: 24H4NWX5CO)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIMER DILINOLEYL DIMER DILINOLEATE (UNII: 0E2D5DBT7M)
DIGLYCERYL SEBACATE/ISOPALMITATE (UNII: XK79T95N8Z)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
GOAT MILK (UNII: XE5K5I4RP7)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN OIL (UNII: 8470G57WFM)
SYNTHETIC WAX (540 MW) (UNII: DW2TC44JRY)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
CERESIN (UNII: Q1LS2UJO3A)
QUERCETIN (UNII: 9IKM0I5T1E)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
IRON OXIDES (UNII: 1K09F3G675)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA (UNII: ETJ7Z6XBU4)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-168-01	1 in 1 CARTON	01/01/2024
1		17 mg in 1 TUBE, WITH APPLICATOR; 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	01/01/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-168)