WOODSLEEP TALLOW SUNSCREEN- titanium dioxide cream

WOODSLEEP Tallow Sunscreen by

Drug Labeling and Warnings

WOODSLEEP Tallow Sunscreen by is a Otc medication manufactured, distributed, or labeled by Shantou Woodsleep Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHEN USING

1. Clean skin and keep it dry.

2. 20-30 minutes before going out, take an appropriate amount of sunscreen and apply it evenly on the face, neck, arms and other parts.

3. Gently massage with fingertips until completely absorbed.

PURPOSE

1. Effectively block ultraviolet rays, build a natural protective barrier for the skin, and protect against the sun with peace of mind.

2. The unique formula deeply moisturizes and lasts for a long time, preventing the skin from drying out due to sun exposure, and keeping the skin moisturized and tender.

3. The soothing formula reduces skin irritation, relieves discomfort after sun exposure, and gives gentle care to the skin, suitable for all skin types.

DO NOT USE

Discontinue use if signs of irritation or rash occur.

STOP USE

Discontinue use if signs of irritation or rash occur.

KEEP OUT OF REACH OF CHILDREN

Please keep out of reach of children. Do not swallow.

WARNINGS

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

STORAGE AND HANDLING

Store in a cool and dry place.

INACTIVE INGREDIENT

AQUA、TITANIUM DIOXIDE、ETHYLHEXYL METHOXYCINNAMATE、ISONONYL ISONONANOATE、GLYCERYL STEARATE、TOCOPHEROL

INDICATIONS & USAGE

ACTIVE INGREDIENT

TALLOW

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WOODSLEEP TALLOW SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85053-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TALLOW (UNII: 98HPY76U4W) (TALLOW - UNII:98HPY76U4W)	TALLOW	0.012 mg  in 60 mg

Inactive Ingredients
Ingredient Name	Strength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)	2.4 mg  in 60 mg
TOCOPHEROL (UNII: R0ZB2556P8)	0.012 mg  in 60 mg
GLYCERYL STEARATE (UNII: 230OU9XXE4)	1.2 mg  in 60 mg
AQUA (UNII: 059QF0KO0R)	35.976 mg  in 60 mg
ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51)	5.4 mg  in 60 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	15 mg  in 60 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85053-003-01	60 mg in 1 BOX; Type 0: Not a Combination Product	04/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/28/2025

Labeler - Shantou Woodsleep Biotechnology Co., Ltd. (699296106)

Registrant - Shantou Woodsleep Biotechnology Co., Ltd. (699296106)

Establishment
Name	Address	ID/FEI	Business Operations
Shantou Woodsleep Biotechnology Co., Ltd.		699296106	manufacture(85053-003)