Tinted Lip Cream SPF 15

Manufacturer
COSMAX USA, CORPORATION
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:44:29

Label at a glance#

ProductTinted Lip Cream SPF 15
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

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 incl...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 9.82%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-168-01Tinted Lip Cream SPF 151 in 1 CARTONCREAM11
68577-168-01Tinted Lip Cream SPF 1517 mg in 1 TUBE, WITH APPLICATORCREAM171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-168TINTED LIP CREAM SPF 15 (ZINC OXIDE) CREAM [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20241220_29227121-e579-8eea-e063-6394a90a302f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-16868577-168-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29227121-e579-8eea-e063-6394a90a302f2024-12-13WarningsExact identifier
ndc (package): 68577-168-01
ndc (product): 68577-168
ndc11 (package): 68577016801
spl id: 29227121-e57a-8eea-e063-6394a90a302f
spl set id: 29227121-e579-8eea-e063-6394a90a302f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.