SPF 50 MINERAL SUNSCREEN LIP- zinc oxide , titanium dioxide cream

SPF 50 MINERAL SUNSCREEN LIP by

Drug Labeling and Warnings

SPF 50 MINERAL SUNSCREEN LIP by is a Otc medication manufactured, distributed, or labeled by Guangzhou Tata Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 4.85%
Titanium Dioxide 8%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

if used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin agingcaused by the sun.

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes.

Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.lf swallowed, getmedical help or contact Posion Center right away.

DOSAGE & ADMINISTRATION

Directions

·Applyliberally15 minutes before sun exposure·Reapply:·after 80 minutes of swimming orsweating·after towel drying, swimming, or·at least every 2 hours ·children under 6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

.Protect this product from excessive heat and direct sun.Sun alert: Limiting sunexposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects ofthe sun.

INACTIVE INGREDIENT

Water,Dimethicone, lsohexadecane, EthylhexylPalmitate, Butylene Glycol, Glycerin, lsopropyl PalmitateSorbitan Sesquioleate, Cetyl Peg/Ppg-10/ Dimethicone.Silica, Disteardimonium Hectorite, Sodium Chloride,Trimethylsiloxysilicate, Peg-30 Dipolyhydroxystearate,

Tribehenin, Magnesium Stearate, Phenoxyethanol,Triethoxycaprylylsilane Ethylhexylglycerin, PentaerythrityTetra-Di-T-Buty Hydroxyhydrocinnamate

QUESTIONS

Please call:1-817-398-8817 or emus at info@redi-usa.com.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 50 MINERAL SUNSCREEN LIP 
zinc oxide , titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84066-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.85 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOHEXADECANE (UNII: 918X1OUF1E)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84066-104-01	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/03/2024

Labeler - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Registrant - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Tata Biotechnology Co., Ltd.		699605102	manufacture(84066-104)