Label: VANICREAM FACIAL MOISTURIZER BROAD SPECTRUM SPF30- zinc oxide cream
- NDC Code(s): 45334-325-02, 45334-325-04, 45334-325-07
- Packager: Pharmaceutical Specialties Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating
- children under 6 months of age: Ask a doctor
- Sun Protection Measures. 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients purified water, C12-15 alkyl benzoate, isopentyldiol, squalane, glycerin, coco-caprylate/caprate, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, PEG-100 stearate, polyhydroxystearic acid, cetearyl alcohol, sucrose stearate, ceramide EOP, ceramide NG, ceramide NP, ceramide AS, ceramide AP, carnosine, phytosterols, hydrogenated lecithin, dimethicone, triethoxycaprylylsilane, polyacrylate crosspolymer-11, caprylyl glycol, 1,2-hexanediol
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VANICREAM FACIAL MOISTURIZER BROAD SPECTRUM SPF30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45334-325 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.5 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPENTYLDIOL (UNII: 19NOL5474Q) CARNOSINE (UNII: 8HO6PVN24W) SOY STEROL (UNII: PL360EPO9J) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CERAMIDE NP (UNII: 4370DF050B) CERAMIDE 5 (UNII: 7848GX36YB) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) PEG-100 STEARATE (UNII: YD01N1999R) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) SQUALANE (UNII: GW89575KF9) GLYCERIN (UNII: PDC6A3C0OX) CERAMIDE NG (UNII: C04977SRJ5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) SUCROSE STEARATE (UNII: 274KW0O50M) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE AP (UNII: F1X8L2B00J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45334-325-02 1 in 1 CARTON 03/15/2022 1 71 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:45334-325-07 7 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2022 3 NDC:45334-325-04 4 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/15/2022 Labeler - Pharmaceutical Specialties Inc (076499557) Establishment Name Address ID/FEI Business Operations Pharmaceutical Specialties Inc 076499557 label(45334-325) , manufacture(45334-325) , pack(45334-325)
