SKY AND SOL BODY SUNSCREEN SPF50 cream

Sky and Sol Body Sunscreen SPF50 by

Drug Labeling and Warnings

Sky and Sol Body Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Guangzhou Fantesy Biotechnology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 25%

Purpose

Sunscreen

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

For external use only.

Do not use

Do not use on damaged or broken skin.

When using this product

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

Stop use

Stop use and ask a doctor if rash occurs.

Keep out of

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

Directions

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

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKY AND SOL BODY SUNSCREEN SPF50 
sky and sol body sunscreen spf50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-011
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
TALLOW (UNII: 98HPY76U4W)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CYPROHEPTADINE (UNII: 2YHB6175DO)
SILICA (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-011-01	200 g in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/12/2025

Labeler - Guangzhou Fantesy Biotechnology Co.,Ltd (619047084)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-011)