FDA.reportPublic FDA data

CVS Health Medicated Lip Care

Manufacturer
CVS Pharmacy
Effective date
2015-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:35

Label at a glance#

ProductCVS Health Medicated Lip Care
Active ingredientAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE
Label structure10 sections

Indications and uses

• helps prevent sunburn • temporarily protects chapped or cracked lips

Dosage and administration

• 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 of 15 or higher and other sun protection measures including: ▪ Limit time in the sun, especi...

Storage and handling

• protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Avobenzone - Sunscreen

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • temporarily protects chapped or cracked lips

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

mineral oil, ozokerite, petrolatum, tricaprin, flavor, aloe barbadensis leaf extract, cholecalciferol, cocos nucifera (coconut) oil, menthol, retinyl palmitate, tocopheryl acetate, zea mays (corn) oil

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Medicated Lip Care
CVS Medicated Lip Care

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-78059779-780-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
DIMETHICONE92RU3N3Y1OACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
TRICAPRINO1PB8EU98MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHOLECALCIFEROL1C6V77QF41IACT
COCONUT OILQ9L0O73W7LIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CORN OIL8470G57WFMIACT

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
000ab522-1e0f-46ec-9d89-a9433228525ffaefef09-b927-4d6e-95de-6f55da7aa5872020-05-28WarningsExact identifier
spl set id: faefef09-b927-4d6e-95de-6f55da7aa587

Reported adverse events (FAERS/openFDA)#

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