WOODSLEEP SUNSCREEN BALM- titanium dioxide cream

WOODSLEEP Sunscreen Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ARTEMISIA ARGYI LEAF EXTRACT

PURPOSE

1. Helps prevent ultraviolet rays and prevent skin aging and sunburn due to sun exposure.

2. The texture is light and easy to apply evenly without leaving traces, allowing you to enjoy fresh and non-greasy skin.

3. The ingredients are mild, not irritating to the skin, and suitable for all types of skin.

WHEN USING

1. Clean skin and keep it dry

2. Take an appropriate amount of this product and apply it evenly on the desired skin

3. Massage gently for complete absorption.

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.

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.

STORAGE AND HANDLING

Store in a cool and dry place.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

1. Clean skin and keep it dry

2. Take an appropriate amount of this product and apply it evenly on the desired skin

3. Massage gently for complete absorption.

INDICATIONS & USAGE

1. Clean skin and keep it dry

2. Take an appropriate amount of this product and apply it evenly on the desired skin

3. Massage gently for complete absorption.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WOODSLEEP SUNSCREEN BALM 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85053-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ) (ARTEMISIA ARGYI LEAF - UNII:2JYC99Q0WZ)	ARTEMISIA ARGYI LEAF	0.012 mg  in 60 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.6 mg  in 60 mg
GLYCERYL STEARATE (UNII: 230OU9XXE4)	0.9 mg  in 60 mg
OCTOCRYLENE (UNII: 5A68WGF6WM)	3 mg  in 60 mg
ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51)	3 mg  in 60 mg
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)	2.4 mg  in 60 mg
AQUA (UNII: 059QF0KO0R)	50.088 mg  in 60 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85053-004-01	60 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/13/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Shantou Woodsleep Biotechnology Co., Ltd.		699296106	manufacture(85053-004)