TINTED FACIAL SUNSCREEN- zinc oxide, titanium dioxide cream

TINTED FACIAL SUNSCREEN by

Drug Labeling and Warnings

TINTED FACIAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Guangzhou Tata Biotechnology Co., Ltd., Guangzhou Tata Biological Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 11%.
Titanium Dioxide 5.6%

PURPOSE

Sunscreen

INDICATIONS & USAGE

helps prevent sunburnifused as directed with other sun protection measures (seeDirections),decreases the risk of skin cancer and early skinaging caused 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. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging
thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts,pants,hats and sunglasses.

Children under 6 months of age : Ask a doctor.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Water, lsononyl lsononanoate, Dimethicone, Butylene GlycolGlycerin, Ethylhexyl Palmitate, Phenyl Trimethicone,Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, CetyPeg/Ppg-10/1 Dimethicone, Silica, DisteardimoniumHectorite, Polyhydroxystearic Acid, Sodium Chloride.Acrylates/Dimethicone Copolymer, Dimethicone/VinylDimethicone Crosspolymer, Sodium Pca, Peg-30Dipolyhydroxystearate, Tribehenin, Magnesium Stearate, Ci77492,Phenoxyethanol, Panthenol, Tocopheryl Acetate, Ci77491, Ethylhexylglycerin, Ci77499, Triethoxycaprylylsilane,PentaerythritylTetra-Di-T-Butyl Hydroxyhydrocinnamate,Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.Saccharide lsomerate, Methylpropanediol, Centella AsiaticaExtract, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract, Camellia Sinensis Leaf Extract,Hibiscus Mutabilis Flower Extract,Nelumbium SpeciosumFlower Extract,1.2-Hexanediol,Rosmarinus Officinalis(Rosemary) Leaf Extract, Chamomilla Recutita (MatricariaFlower Exiract, Hyaluronic Acid, Sodium Levulinate,Silanetriol, Citric Acid, P-Anisic Acid

QUESTIONS

You can email us at info@socleare.com for more help!

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED FACIAL SUNSCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84066-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.6 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PANTHENOL (UNII: WV9CM0O67Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HIBISCUS MUTABILIS FLOWER (UNII: 2O22799NBH)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
JOJOBA OIL (UNII: 724GKU717M)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
PRUNUS MUME FLOWER (UNII: 2N8872050J)
ROSEMARY (UNII: IJ67X351P9)
CHAMOMILE (UNII: FGL3685T2X)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HYALURONIC ACID (UNII: S270N0TRQY)
SILANETRIOL (UNII: E52D0J3TS5)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84066-102-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/21/2024

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Tata Biological Technology Co., Ltd.		699605102	manufacture(84066-102)