Label: RESIST WRINKLE DEFENSE SPF 30 PAULAS CHOICE- zinc oxide cream
- NDC Code(s): 56152-5003-1, 56152-5003-2
- Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or seating:
- Immediately after towel dyring
- At least every two hours
- Children under 6 months of age: Ask a doctor
Sun ProtectionMeasures. 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 of 15 or higher and other sun protection measures, including:
- Limit tim in the sun, especially from 10a.m.-2p.m.
- Wear long-sleeve shirts, pants, hats and sunglasses
-
INACTIVE INGREDIENT
Water (Aqua), Cyclopentasiloxane, PEG-12 Dimethicone, PEG/PPG-18/18 Dimethicone, Lauroyl Lysine, Sodium Chloride, Trihydroxystearin, Dimethicone Crosspolymer, Resveratrol, Quercetin, Epigalloactechin Gallate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Adenosine, Bisabolol, Salix Alba (Willow) Bark Extract, Punica Granatum (Pomegranate) Extract, Haematococus Pluvialis Extract, Hydrolyzed Corn Starch, Polysorbate 80, Hydrated Silica, Triethoxycaprylylsilane, C12-15 Alkyl Benzoate, Isopropyl Titanium Triisostearate, Hexylene Glycol, Ethylhexylglycerin, Iron Oxide (CI 77491, CI 77492, CI 77499), Caprylyl Glycol, Phenoxyethanol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RESIST WRINKLE DEFENSE SPF 30 PAULAS CHOICE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-5003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) LAUROYL LYSINE (UNII: 113171Q70B) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) RESVERATROL (UNII: Q369O8926L) QUERCETIN (UNII: 9IKM0I5T1E) EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ADENOSINE (UNII: K72T3FS567) LEVOMENOL (UNII: 24WE03BX2T) SALIX ALBA BARK (UNII: 205MXS71H7) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-5003-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 08/10/2016 2 NDC:56152-5003-2 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 08/10/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/10/2016 Labeler - Cosmetic Enterprises Ltd (017701475)
