FDA.reportPublic FDA data

sunscreen lip balm

Manufacturer
NingBo Huize Commodity Co.,Ltd.
Effective date
2018-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:59

Label at a glance#

Productsunscreen lip balm
Active ingredientOCTINOXATE, PADIMATE O
Label structure6 sections

Dosage and administration

Directions ■Apply liberally 15 minutes before sun exposure ■after 80 minutes of swimming or sweating, immediately after towel drying. ■To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher ■at least every 2 hours. ■ Spending time in the sun increases your risk of skin cancer and early skin aging

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octylmethoxycinnamate 4%,
2-ethylhexyl 4-(dimethylamino)benzoate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.
When using this products
■apply to the lips
■Lips are the softest part of your face and the most exposed to Constant exposure to sun ,air,dust,pollution,bacteria and a variety of food items,makes the lips dry
■They need a little extra care and protection to retain their softness
■These lip balm ingredients are harmless to your tender skin which makes lip balm an absolutely safe product to use.
Stop use and ask a doctor if rash occurs

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
■Apply liberally 15 minutes before sun exposure
■after 80 minutes of swimming or sweating, immediately after towel drying.
■To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher
■at least every 2 hours.
■ Spending time in the sun increases your risk of skin cancer and early skin aging

Inactive ingredients

INACTIVE INGREDIENT SECTION

Synthetic wax,Hydrogenated polyisobutene,liquid paraffin ,flavor,Vitamin E

lebel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71011-002-012020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-022020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-032020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-042020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-052020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-062020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-072020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-082020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-092020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-112020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-122020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-132020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-142020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-152020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-162020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm
71011-002-172020-01-31C16284748780-19d75b9d0-f412-f424-e053-dadaa90a57cesunscreen lip balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71011-002-01sunscreen lip balm10 g in 1 PACKAGESTICK102
71011-002-02sunscreen lip balm13 g in 1 PACKAGESTICK132
71011-002-03sunscreen lip balm14 g in 1 PACKAGESTICK142
71011-002-04sunscreen lip balm15 g in 1 PACKAGESTICK152
71011-002-05sunscreen lip balm16 g in 1 PACKAGESTICK162
71011-002-06sunscreen lip balm19 g in 1 PACKAGESTICK192
71011-002-07sunscreen lip balm20 g in 1 PACKAGESTICK202
71011-002-08sunscreen lip balm25 g in 1 PACKAGESTICK252
71011-002-09sunscreen lip balm30 g in 1 PACKAGESTICK302
71011-002-11sunscreen lip balm3 g in 1 PACKAGESTICK32
71011-002-12sunscreen lip balm4 g in 1 PACKAGESTICK42
71011-002-13sunscreen lip balm5 g in 1 PACKAGESTICK52
71011-002-14sunscreen lip balm6 g in 1 PACKAGESTICK62
71011-002-15sunscreen lip balm7 g in 1 PACKAGESTICK72
71011-002-16sunscreen lip balm8 g in 1 PACKAGESTICK82
71011-002-17sunscreen lip balm9 g in 1 PACKAGESTICK92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71011-002SUNSCREEN LIP BALM (PADIMATE O,OCTINOXATE) STICK [NINGBO HUIZE COMMODITY CO.,LTD.]2Legacy NDC, 16 package rows20180108_3f42326a-6b33-31eb-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71011-00271011-002-01, 71011-002-02, 71011-002-03, 71011-002-04, 71011-002-05, 71011-002-06, 71011-002-07, 71011-002-08, 71011-002-09, 71011-002-11, 71011-002-12, 71011-002-13, 71011-002-14, 71011-002-15, 71011-002-16, 71011-002-17

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
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
PARAFFINI9O0E3H2ZEIACT
VITAMIN A MYRISTATE7H32T49054IACT
1.ALPHA.,24S-DIHYDROXYVITAMIN D22900I92Z36IACT
OCTINOXATE4Y5P7MUD51ACTIB
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
PADIMATE OZ11006CMUZACTIB

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
621702a3-9d4f-4663-e053-2991aa0a5f383f42326a-6b33-31eb-e054-00144ff88e882018-01-06WarningsExact identifier
spl id: 621702a3-9d4f-4663-e053-2991aa0a5f38
spl set id: 3f42326a-6b33-31eb-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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