FDA.reportPublic FDA data

JESS BEAUTY Sun Drops Sunscreen Oil SPF-50

Manufacturer
JESS BEAUTY PRODUCTS LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:57

Label at a glance#

ProductJESS BEAUTY Sun Drops Sunscreen Oil SPF-50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure7 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. 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

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun...

Label contents#

Full prescribing information#

Active Ingredientes

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • 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.

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.

Stop use and ask doctor if 

OTC - STOP USE SECTION

rash occours.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every two hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures
  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Adansonia Digitata (Baobab) Oil, Aloe Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Dimethicone/Bis-isobutyl PPG-20 Crosspolymer, Isododecane, Squalane, Tocopherol (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83542-409-00JESS BEAUTY Sun Drops Sunscreen Oil SPF-5030 mL in 1 TUBELOTION302
83542-409-00JESS BEAUTY Sun Drops Sunscreen Oil SPF-501 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83542-409JESS BEAUTY SUN DROPS SUNSCREEN OIL SPF-50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [JESS BEAUTY PRODUCTS LLC]2Current NDC, 2 package rows20231106_4e05e9d6-5127-44ca-a331-3004b2ddb534.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
83542-40983542-409-00

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
ALOEV5VD430YW9IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CARROTL56Z1JK48BIACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
ISODODECANEA8289P68Y2IACT
SQUALANEGW89575KF9IACT
TOCOPHEROLR0ZB2556P8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
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
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC4e05e9d6-5127-44ca-a331-3004b2ddb5342023-11-06WarningsExact identifier
ndc (package): 83542-409-00
ndc (product): 83542-409
ndc11 (package): 83542040900
spl id: 0976c569-76fc-ecde-e063-6394a90a76b1
spl set id: 4e05e9d6-5127-44ca-a331-3004b2ddb534

Reported adverse events (FAERS/openFDA)#

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