FDA.reportPublic FDA data

sunscreen

Manufacturer
Humphreyline
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:50

Label at a glance#

Productsunscreen
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

INACTIVE INGREDIENT SECTION

Mineral Oil, Beeswax, Petrolatum, Paraffin, Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Toxopheryl Acetate, Propylparaben, Aloe Juice

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 min before sun exposure. Use a 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 - 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm. Wear long sleeved shirts, pants, hats, and sunglasses.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Raining Rose Lip BalmRaining Rose Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
19392-310-012022-01-28C16284748780-1d6a99b39-3f78-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
19392-310-01sunscreen4 g in 1 BOTTLE, PLASTICLIPSTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
19392-310SUNSCREEN (OCTINOXATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE) LIPSTICK [HUMPHREYLINE]1Legacy NDC, 1 package rows20200610_a6b7ce85-cb3d-4c40-e053-2995a90a3bf2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
19392-31019392-310-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
PETROLATUM4T6H12BN9UIACT
ETHYLHEXYL PALMITATE2865993309IACT
YELLOW WAX2ZA36H0S2VIACT
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
CETYL ALCOHOL936JST6JCNIACT
ALOEV5VD430YW9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
a6b79864-8e2b-45ae-e053-2a95a90a70dda6b7ce85-cb3d-4c40-e053-2995a90a3bf22020-05-28WarningsExact identifier
spl id: a6b79864-8e2b-45ae-e053-2a95a90a70dd
spl set id: a6b7ce85-cb3d-4c40-e053-2995a90a3bf2

Reported adverse events (FAERS/openFDA)#

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