100% MINERAL SUNSCREEN cream

100% MINERAL SUNSCREEN by

Drug Labeling and Warnings

100% MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Guangzhou Pallas Cosmetics Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Zin Oxide 1 5.%
Titanium Dioxide 10%

Purpose

Sunscreen

Use

Use Protect UVA and UVB rays and support sun protection.

Warnings

For external use only.

Do not use

DO not use if you are allergic to any of the ingredient.

WHEN USING

When using this product do not get into eyes. if contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irrita tion or rash develops and continues for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Adults and children 2 years and over：Apply sunscreen 15 minutes on skin before sun exposure.

Children under2 years： Ask doctor before use.

Other information

No

Inactive ingredients

Purified Water, Caprylic/Capric Triglyceride, Cety| Peg/Ppg-10/1 Dimethicone, Glycerin, Sorbitan Sesquioleate，
Magnesium Sulfate, Tocopherol, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate,
Chamomilla Recutita Flower E xtract, Citrus Paradisi (Grapefruit) Peel Oil, Centella Asiatica Root Extract,
Rubus ldaeus (Raspberry) Seed Oil, Carica Papaya (Papaya) Fruit Extract, Hydrogenated Castor Oil,
Hydroxyacetophenone, Hexylene Glycol.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

100% MINERAL SUNSCREEN 
100% mineral sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84484-001
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
ALLANTOIN (UNII: 344S277G0Z)
CHAMOMILE (UNII: FGL3685T2X)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MAGNESIUM SULFATE (UNII: DE08037SAB)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CITRUS PARADISI (GRAPEFRUIT) PEEL OIL (UNII: YR377U58W9)
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)
CARICA PAPAYA (PAPAYA) FRUIT (UNII: KU94FIY6JB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84484-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/14/2025

Labeler - Guangzhou Pallas Cosmetics Co.,Ltd. (419564106)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Pallas Cosmetics Co.,Ltd.		419564106	manufacture(84484-001)