Label: ELROEL PANG PANG SUN CUSHION PLUS- zinc oxide, titanium dioxide, octinoxate, octisalate cream
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NDC Code(s):
83154-004-01,
83154-004-02,
83154-004-03,
83154-004-04, view more83154-004-05, 83154-004-06
- Packager: MONOGLOT HOLDINGS Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 20, 2025
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply at least every two hours
■ use a water resistant sunscreen if swimming or sweating
■ 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
■ children under 6 months of age: ask a doctor - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELROEL PANG PANG SUN CUSHION PLUS
zinc oxide, titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83154-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.52 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 9.7 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SHEA BUTTER (UNII: K49155WL9Y) ADENOSINE (UNII: K72T3FS567) XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) ANHYDROXYLITOL (UNII: 8XWR7NN42F) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) LAMINARIA JAPONICA (UNII: WE98HW412B) ULMUS DAVIDIANA ROOT (UNII: URQ79U8261) VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X) DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356) XYLITOL (UNII: VCQ006KQ1E) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) YELLOW WAX (UNII: 2ZA36H0S2V) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) SUCROSE STEARATE (UNII: 274KW0O50M) STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PEG-100 STEARATE (UNII: YD01N1999R) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) MADECASSOSIDE (UNII: CQ2F5O6YIY) MADECASSIC ACID (UNII: M7O1N24J82) ASIATICOSIDE (UNII: PKO39VY215) ASIATIC ACID (UNII: 9PA5A687X5) ALOE VERA LEAF (UNII: ZY81Z83H0X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) AMILOXATE (UNII: 376KTP06K8) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) NIACINAMIDE (UNII: 25X51I8RD4) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIPROPYLENE GLYCOL (UNII: E107L85C40) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83154-004-02 1 in 1 CARTON 02/03/2024 1 NDC:83154-004-01 15 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:83154-004-04 1 in 1 CARTON 01/20/2025 2 NDC:83154-004-03 8 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:83154-004-06 1 in 1 CARTON 01/20/2025 3 NDC:83154-004-05 25 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/03/2024 Labeler - MONOGLOT HOLDINGS Inc. (694628175) Registrant - MONOGLOT HOLDINGS Inc. (694628175) Establishment Name Address ID/FEI Business Operations Cit Co., Ltd. 690081646 manufacture(83154-004)