SKY AND SOL SUNSCREEN SPF50 cream

Sky and Sol Sunscreen SPF50 by

Drug Labeling and Warnings

Sky and Sol 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 INGREDIENT

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

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.

DO NOT USE

Do not use on damaged or broken skin.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Directions
■ shake well before use
■ apply liberally 15 minutes before sun exposure
■ reapply: 1.after 80 minutes of swimming or sweating. 2. immediately after towel drying. 3.at least every 2 hours

■children after 6 months of age: ask a doctor
■Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularlyuse a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including.
1. limit time in the sun, especially from 10am-2pm
2. wear long-sleeve shirts, pants, hats, and sunglasses

Other information

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

Inactive Ingredients

Tallow, Jojoba Oil, Cera Alba（Beeswax）, Simmondsia Chinensis(Jojoba)Oil, Propolis

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKY AND SOL SUNSCREEN SPF50 
sky and sol sunscreen spf50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-006
Route of Administration	TOPICAL

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
YELLOW WAX (UNII: 2ZA36H0S2V)
BEEF TALLOW (UNII: 98HPY76U4W)
JOJOBA OIL (UNII: 724GKU717M)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-006-01	85 g in 1 BOX; Type 0: Not a Combination Product	07/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/04/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-006)