FDA.reportPublic FDA data

Remedy Lip Balm

Manufacturer
Medline Industries, LP
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:24

Label at a glance#

ProductRemedy Lip Balm
Active ingredientOCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

apply liberally 15 minutes before sun exposure and as needed use water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age: ask a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts

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.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure and as needed
  • use water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: ask a doctor.

Sun Protection Measures:

OTHER SAFETY INFORMATION

spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10am-2pm. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arnica montana flower extract, beeswax*, butyrospermum parkii (shea) butter*, calendula officinalis flower extract*, citrus aurantifolia (lime) oil, citrus aurantium dulcis (orange) peel oil, citrus limon (lemon) peel oil, citris paradisi (grapefruit) peel oil, copernicia cerifera (carnauba) wax*, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, mangifera indica (mango) seed butter, persea gratissima (avocado) oil*, pisum sativum (pea) protein, prunus armeniaca (apricot) kernel oil*, ricinus communis (castor) seed oil*, rubus idaeus (raspberry) leaf extract*, salix alba (willow) bark extract, symphytum officinale leaf extract, tocopherol, vitis vinifera (grape) seed oil*, zingiber officinale (ginger) root oil*. *Certified Organic Ingredient - Contains No Animal Fats - Gluten Free

Other information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-99753329-997-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
AVOCADO OIL6VNO72PFC1IACT
OCTOCRYLENE5A68WGF6WMACTIB
SHEA BUTTERK49155WL9YIACT
GRAPEFRUIT OILYR377U58W9IACT
APRICOT KERNEL OIL54JB35T06AIACT
RUBUS IDAEUS LEAF8O2V33JG64IACT
LIME OILUZH29XGA8GIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ORANGE OILAKN3KSD11BIACT
PEA PROTEIN7Q50F46595IACT
CASTOR OILD5340Y2I9GIACT
GRAPE SEED OIL930MLC8XGGIACT
SALIX ALBA BARK205MXS71H7IACT
ALOE VERA LEAFZY81Z83H0XIACT
GINGER OILSAS9Z1SVUKIACT
CARNAUBA WAXR12CBM0EIZIACT
AVOBENZONEG63QQF2NOXACTIB
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
LEMON OILI9GRO824LLIACT
COMFREY LEAFDG4F8T839XIACT
TOCOPHEROLR0ZB2556P8IACT

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
0321e1c0-6a02-c146-e063-6294a90acfe69cd48ea5-7674-4fb2-e053-2a95a90a7f952023-08-17WarningsExact identifier
spl set id: 9cd48ea5-7674-4fb2-e053-2a95a90a7f95

Reported adverse events (FAERS/openFDA)#

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