FDA.reportPublic FDA data

Sky and Sol Body Sunscreen SPF50

Manufacturer
Guangzhou Fantesy Biotechnology Co.,Ltd
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:03

Label at a glance#

ProductSky and Sol Body Sunscreen SPF50
Active ingredientZINC OXIDE
Label structure12 sections

Indications and 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

1.shake well before use 2.apply liberally 15 minutes before sun exposure 3.reapply:●after 80 minutes of swimming or sweating ●immediately after towel drying●at least every 2 hours 4.children after 6 months of age: ask a doctor 5.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 of 15 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

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

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of

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

1.shake well before use
2.apply liberally 15 minutes before sun exposure
3.reapply:●after 80 minutes of swimming or sweating ●immediately after towel drying●at least every 2 hours
4.children after 6 months of age: ask a doctor
5.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 of 15 or higher and other sun protection
measures including:
●limit time in the sun, especially from 10am-2pm
●wear long-sleeve shirts, pants, hats, and sunglasses

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Tllow, Olea Europaea (Olive) Oil, Butyrospermum Parki Butter (Shea Butter), Lecithin,
Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9917ef47-291c-0597-9549-0221b002efcdProduct name720210804
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6bProduct name520190821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-011-01Sky and Sol Body Sunscreen SPF50200 g in 1 BOTTLECREAM2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83447-011SKY AND SOL BODY SUNSCREEN SPF50 CREAM [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD]1Current NDC, 1 package rows20250214_2de9173b-fa02-8017-e063-6394a90ae0aa.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83447-01183447-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AQUA059QF0KO0RIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
TALLOW98HPY76U4WIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CYPROHEPTADINE2YHB6175DOIACT
SILICAETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
ZINC OXIDESOI2LOH54ZACTIB

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
Sky and Sol Body Sunscreen SPF50SKY AND SOL BODY SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd2de9173b-fa02-8017-e063-6394a90ae0aa2025-02-11WarningsExact identifier
ndc (package): 83447-011-01
ndc (product): 83447-011
ndc11 (package): 83447001101
spl id: 2de8eee3-2b76-6db6-e063-6394a90aafe3
spl set id: 2de9173b-fa02-8017-e063-6394a90ae0aa

Reported adverse events (FAERS/openFDA)#

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