FDA.reportPublic FDA data

DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen

Manufacturer
Guangzhou Fantesy Biotechnology Co.,Ltd
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:11

Label at a glance#

ProductDALLAS JAMES SKINCARE CO. SPF 50 Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

uses 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.

Dosage and administration

apply liberally 15 minutes before sun exposure & reapply: ■after 40 minutes of swimming or sweating ■immediately after towel drying ■at least every 2 hours

Storage and handling

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 10 a.m.-2 p.m. ■ wear long-sleeve shirts, pants, hats, and sunglasses. ■children under 6 n mornths: ask a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24%

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION

uses 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

① For external use only.

② When using this product keep out of eyes.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

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

apply liberally 15 minutes before sun exposure & reapply:
■after 40 minutes of swimming or sweating
■immediately after towel drying
■at least every 2 hours

Other information

STORAGE AND HANDLING SECTION

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 10 a.m.-2 p.m.
■ wear long-sleeve shirts, pants, hats, and sunglasses.
■children under 6 n mornths: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aqua, aloe barbadensis leaf juice, caprylic/ capric triglycerides, sorbitan stearate, polyglyceryl-4 isostearate, hexyl laurate, cetyl
dimethicone, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, citrullus lanatus
(watermelon) fruit extract, rubus chamaemorus (cloudberry) fruit extract, niacinamide, centella asiatica extract, ceramide NP,
tocopherol (vitamin e), citrus limon (lemon) fruit extract, sodium hyaluronate, watermelon essential oil, potassium sorbate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-010-01DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen50 mL in 1 BOTTLECREAM502

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83447-01083447-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
COCONUT OILQ9L0O73W7LIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
LEMON24RS0A988OIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
TOCOPHEROLR0ZB2556P8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
HEXYL LAURATE4CG9F9W01QIACT
ZINC OXIDESOI2LOH54ZACTIB
CERAMIDE NSV7M2259XJMIACT
JOJOBA OIL724GKU717MIACT
WATERMELON231473QB6RIACT
NIACINAMIDE25X51I8RD4IACT

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
DALLAS JAMES SKINCARE CO. SPF 50 SunscreenDALLAS JAMES SKINCARE CO. SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd225faeec-4f96-e082-e063-6394a90a9a312026-01-05WarningsExact identifier
ndc (package): 83447-010-01
ndc (product): 83447-010
ndc11 (package): 83447001001
spl id: 479ede96-3c89-57cd-e063-6394a90afcb3
spl set id: 225faeec-4f96-e082-e063-6394a90a9a31

Reported adverse events (FAERS/openFDA)#

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