Label: IMPECCABLE SKIN - IVORY- zinc oxide cream
IMPECCABLE SKIN - BUFF- zinc oxide cream
IMPECCABLE SKIN - SAND- zinc oxide cream
IMPECCABLE SKIN - TAN- zinc oxide cream
IMPECCABLE SKIN - BRONZE- zinc oxide cream
IMPECCABLE SKIN - NUDE- zinc oxide cream
IMPECCABLE SKIN - MOCHA- zinc oxide cream
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NDC Code(s):
69949-151-01,
69949-152-01,
69949-153-01,
69949-154-01, view more69949-155-01, 69949-156-01, 69949-157-01
- Packager: Synchronicity Spa, Inc. DBA Suntegrity
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 5, 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
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
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 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, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Melanin, Bisabolol, Hyaluronic Acid, Camellia Sinensis Leaf Extract, Phospholipids, Polyglyceryl-2 Stearate, Sodium Chloride, Propylene Carbonate, Isopropyl Titanium Triisostearate, Titanium Dioxide (C.I.77891), Iron Oxides (C.I.77492, C.I. 77491, C.I.77499)
- Other information
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Ivory
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Buff
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Sand
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Tan
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Bronze
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Nude
- PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Mocha
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INGREDIENTS AND APPEARANCE
IMPECCABLE SKIN - IVORY
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-151-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 08/01/2018 IMPECCABLE SKIN - BUFF
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-152 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-152-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 08/01/2018 IMPECCABLE SKIN - SAND
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-153 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-153-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 08/01/2018 IMPECCABLE SKIN - TAN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-154 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-154-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 08/01/2018 IMPECCABLE SKIN - BRONZE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-155 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-155-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 08/01/2018 IMPECCABLE SKIN - NUDE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-156 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-156-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 12/01/2019 IMPECCABLE SKIN - MOCHA
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) HYALURONIC ACID (UNII: S270N0TRQY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-157-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 10/01/2023 Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)
