TINTED WATERY SUNSCREEN- titanium dioxide, zinc oxide lotion

TINTED WATERY SUNSCREEN by

Drug Labeling and Warnings

TINTED WATERY SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by KSISTERS PTE. LTD., COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide

Zinc Oxide

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

For external use only

Do not use on damaged or broken skin

When using this 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- limit time in the sun, especially from 10a.m. - 2p.m.

- wear long-resistant shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Ethylhexyl Methoxycinnamate, Cyclopentasiloxane, Butyloctyl Salicylate, Ethylhexyl Salicylate, Dipropylene Glycol, Cyclohexasiloxane, Butylene Glycol, Caprylyl Methicone, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl,, Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, PEG-10 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Silica, Sorbitan lsostearate, 1,2-Hexanediol, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, lsododecane, Octyldodecanol, Aluminum Hydroxide, Stearic Acid, Dimethicone, DimethiconeNinyl, Dimethicone Crosspolymer, Polyglyceryl-4 lsostearate, Ethylhexylglycerin, lsopropyl Titanium Triisostearate, Adenosine, Glycerin, Disodium EDTA, Pentylene Glycol, Bacillus Ferment, Micrococcus Lysate, Acetyl Glucosamine, BHT, Sodium Hyaluronate, Hydroxyacetophenone, Cynanchum Atratum Extract, Tocopherol, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Pentaerythrityl Tetra-di-I-butyl Hydroxyhydrocinnamate, Caprvlvl Glycol, Iron Oxides (Cl 77492, CI77491)

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED WATERY SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87487-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.22 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)
ISODODECANE (UNII: A8289P68Y2)
ACETYL GLUCOSAMINE (UNII: V956696549)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
SODIUM HYALURONATE CROSSPOLYMER-1 (UNII: 4D4QKG9VN2)
MAGNESIUM SULFATE (UNII: DE08037SAB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TOCOPHEROL (UNII: R0ZB2556P8)
NIACINAMIDE (UNII: 25X51I8RD4)
LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (UNII: 35J49U6PZS)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
VINCETOXICUM ATRATUM WHOLE (UNII: U3176B0S5J)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BACILLUS SUBTILIS (UNII: 8CF93KW41W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
BHT (UNII: 1P9D0Z171K)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87487-100-02	1 in 1 BOX	03/13/2026
1	NDC: 87487-100-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/13/2026

Labeler - KSISTERS PTE. LTD. (595458762)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(87487-100)