SKY AND SOL SPF25 LIP BALM paste

Sky and Sol SPF25 Lip Balm by

Drug Labeling and Warnings

Sky and Sol SPF25 Lip Balm 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

Non-Nano Zinc Oxide 15%

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

① For external use only.

② When using this product keep out of eyes. Rinse with water to remove.
③ Stop use and ask a doctor if rash occurs.

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: ●after 80 minutes of swimming or sweating ●immediately after towel drying ●at least every 2 hours
■ children after 6 months of age: ask a doctor

Other information

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

Inactive Ingredients

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis)，
Camellia Sinensis (Green Tea) Leaf Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKY AND SOL SPF25 LIP BALM 
sky and sol spf25 lip balm paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BEEF TALLOW (UNII: 98HPY76U4W)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-009-01	9 g in 1 BOX; Type 0: Not a Combination Product	08/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/09/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-009)