SPF 50 MINERAL SUNSCREEN LIP

Drug Details [pdf]

SPF 50 MINERAL SUNSCREEN LIP- zinc oxide , titanium dioxide cream
Guangzhou Tata Biotechnology Co., Ltd.

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SPF 50 MINERAL SUNSCREEN LIP

Zinc Oxide 4.85%
Titanium Dioxide 8%

Sunscreen

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.

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.lf swallowed, getmedical help or contact Posion Center right away.

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.

.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.

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

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

labeling

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
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)
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/03/2024	12/31/2024

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

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

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

Revised: 11/2024

Document Id: 28089270-536d-3523-e063-6394a90a033f

Set id: 1c6f0964-9bee-1c06-e063-6294a90ac2a4

Version: 2

Effective Time: 20241129

SPF 50 MINERAL SUNSCREEN LIP

SPF 50 MINERAL SUNSCREEN LIP by

Drug Labeling and Warnings

Drug Details [pdf]

SPF 50 MINERAL SUNSCREEN LIP