FDA.reportPublic FDA data

SUNSCREEN LIP BALM

Manufacturer
Guangzhou Tata Biotechnology Co., Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:27:39

Label at a glance#

ProductSUNSCREEN LIP BALM
Active ingredientPOLYSILICONE-15, OCTOCRYLENE, OCTINOXATE, HOMOSALATE, AVOBENZONE
Label structure13 sections

Storage and handling

Other information protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Ethylhexyl Methoxycinnamate 7%
Homosalate 6 %
Polysilicone-15 5%
Octocrylene 5%
Butyl Methoxydibenzoylmethane 2%

OTC - PURPOSE SECTION

Sunscreen

INACTIVE INGREDIENT SECTION

lnactive ingredients：Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax，Fragrance, Tocopherol， Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil，12-Hexanediol, Citric Acid

OTC - QUESTIONS SECTION

Questions or comments?

+1-973-907-6739

INDICATIONS & USAGE SECTION

helps prevent sumburn
if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. lf swallowed, get medical help or contact a Poison
Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts,pants,hats and sunglasses

STORAGE AND HANDLING SECTION

Other information protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84066-101-01SUNSCREEN LIP BALM3.2 g in 1 TUBELIPSTICK3.25

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84066-10184066-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSILICONE-15F8DRP5BB29ACTIB
SUNFLOWER OIL3W1JG795YIIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
SHEA BUTTERK49155WL9YIACT
OCTOCRYLENE5A68WGF6WMACTIB
HYDROGENATED COCONUT OILJY81OXM1OMIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
ALOE ARBORESCENS LEAF09TD8L5SQVIACT
CERESINQ1LS2UJO3AIACT
JOJOBA OIL724GKU717MIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
PARAFFINI9O0E3H2ZEIACT
AVOBENZONEG63QQF2NOXACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
GRAPE SEED OIL930MLC8XGGIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYL PALMITATE2865993309IACT
TOCOPHEROLR0ZB2556P8IACT
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT

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
SUNSCREEN LIP BALMETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.0f8e08bf-4b14-bdad-e063-6394a90a34e12025-12-22WarningsExact identifier
ndc (package): 84066-101-01
ndc (product): 84066-101
ndc11 (package): 84066010101
spl id: 4686f9b1-07a5-74cc-e063-6394a90a3afa
spl set id: 0f8e08bf-4b14-bdad-e063-6394a90a34e1

Reported adverse events (FAERS/openFDA)#

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