FDA.reportPublic FDA data

NYU Langone Health Lip Balm

Manufacturer
Guangdong Aimu Biological Technology Co., Ltd
Effective date
2025-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:05:49

Label at a glance#

ProductNYU Langone Health Lip Balm
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Apply liberally and evenly 15 minutes prior to sunexposure. Reapply after 40 minutes of swimming or sweating immediately after towel drying "at least every 2 hours.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 0.2%

Purpose

OTC - PURPOSE SECTION

Lip sun protection

Uses

INDICATIONS & USAGE SECTION

Apply liberally and evenly 15 minutes prior to sunexposure.
Reapply after 40 minutes of swimming or sweating immediately after towel drying "at least every 2 hours.

Warnings

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

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.

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.

Dosage

DOSAGE & ADMINISTRATION SECTION

Squeeze out an appropriate amount of Sunscreen lip balm and spread evenly on your lips.

Inactive ingredients

INACTIVE INGREDIENT SECTION

PETROLATUM：69%
CERA MICROCRISTALLINA：13%
BEESWAX：5%
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL：5%
MINERAL OIL：4.4%
BUTYROSPERMUM PARKII(SHEA) BUTTER：2%
MEL：1%
COCOS NUCIFERA (COCONUT) OIL：0.2%
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL：0.2%

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.Label.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83566-558-01NYU Langone Health Lip Balm5 g in 1 TUBELIPSTICK51

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83566-55883566-558-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
MINERAL OILT5L8T28FGPIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
BEESWAX2ZA36H0S2VIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
PETROLATUM4T6H12BN9UIACT

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
NYU Langone Health Lip BalmZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd38745b55-8da5-4627-e063-6394a90a24ca2025-06-26WarningsExact identifier
ndc (package): 83566-558-01
ndc (product): 83566-558
ndc11 (package): 83566055801
spl id: 38745b55-8da6-4627-e063-6394a90a24ca
spl set id: 38745b55-8da5-4627-e063-6394a90a24ca

Reported adverse events (FAERS/openFDA)#

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