FDA.reportPublic FDA data

RENEWALUXE SPF 50 Sunscreen

Manufacturer
Guangzhou Fantesy Biotechnology Co.,Ltd
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:25

Label at a glance#

ProductRENEWALUXE SPF 50 Sunscreen
Active ingredientZINC OXIDE
Label structure9 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

Directions Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating ■Immediately after towel drying ■At least every 2 hours ■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: Lim...

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Zinc Oxide 21.8%

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

Warnings
For external use only
Do not use on damaged or broken skin.
When using the product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of
swimming or sweating
■Immediately after towel drying
■At least every 2 hours
■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 10a.m. - 2p.m.
■Wear long-sleeve shirts, pants, hats, and sunglasses.
■Children under 6 months: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-005-01RENEWALUXE SPF 50 Sunscreen50 mL in 1 BOXCREAM504

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83447-00583447-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN MONOSTEARATENVZ4I0H58XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
CERAMIDE 988KCS7120EIACT
TOCOPHEROLR0ZB2556P8IACT
LEMON24RS0A988OIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALOE VERA LEAFZY81Z83H0XIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CETYL DIMETHICONE 45IK315POC44IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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
RENEWALUXE SPF 50 SunscreenRENEWALUXE SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd1bc29960-5e73-e8ab-e063-6294a90a3f802026-01-06WarningsExact identifier
ndc (package): 83447-005-01
ndc (product): 83447-005
ndc11 (package): 83447000501
spl id: 47b31ef5-e027-ed4b-e063-6294a90a2d30
spl set id: 1bc29960-5e73-e8ab-e063-6294a90a3f80

Reported adverse events (FAERS/openFDA)#

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