Label: TINTED FACIAL SUNSCREEN- zinc oxide, titanium dioxide cream
- NDC Code(s): 84066-102-01
- Packager: Guangzhou Tata Biological Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 27, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TINTED FACIAL SUNSCREEN
zinc oxide, titanium dioxide creamProduct 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 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) 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) 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 Biological Technology Co., Ltd. (699605102) Registrant - Guangzhou Tata Biological Technology Co., Ltd. (699605102) Establishment Name Address ID/FEI Business Operations Guangzhou Tata Biological Technology Co., Ltd. 699605102 manufacture(84066-102)
