Label: IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 TAN- zinc oxide cream
- NDC Code(s): 56152-0260-1, 56152-0260-2
- Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 7, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: 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 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
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INACTIVE INGREDIENT
Inactive Ingredients Aloe Barbadensis Leaf Juice, Purified Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Glycerin, Lauroyl Lysine, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, C12-15 Alkyl Benzoate, Stearalkonium Hectorite, Leuconostoc/Radish Root Ferment Filtrate, Dipalmitoyl Hydroxyproline, Tetrahexyldecyl Ascorbate, Tocopherol, Sambucus Nigra Fruit Extract, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Melanin, Bisabolol, Hyaluronic Acid, Camellia Sinensis Leaf Extract, Phospholipids, Polyglyceryl-2 Stearate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Ethylhexylglycerin, Sodium Chloride, Propylene Carbonate, Isopropyl Titanium, Triisostearate, Titanium Dioxide (C.I. 77891) Iron Oxides (C.I. 77492, C.I. 77491, C.I. 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 TAN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-0260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g in 100 g Inactive Ingredients Ingredient Name Strength CAESALPINIA SPINOSA FRUIT EXTRACT (UNII: 2LBT8R6WE6) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) COCONUT (UNII: 3RT3536DHY) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) LACTOBACILLUS (UNII: 5307V7XW8I) ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) KAPPAPHYCUS ALVAREZII EXTRACT (UNII: T479H08K2O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) EUROPEAN ELDERBERRY (UNII: BQY1UBX046) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) LAUROYL LYSINE (UNII: 113171Q70B) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) C13-15 ALKANE (UNII: 114P5I43UJ) TOCOPHEROL (UNII: R0ZB2556P8) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) BISABOLOL (UNII: 24WE03BX2T) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-0260-1 7.1 g in 1 TUBE; Type 0: Not a Combination Product 10/24/2024 2 NDC:56152-0260-2 56.7 g in 1 TUBE; Type 0: Not a Combination Product 10/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/24/2024 Labeler - Cosmetic Enterprises Ltd (017701475)