Label: DR. ESLEE PHYSICAL SUNSCREEN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82700-0002-1 - Packager: dr.eslee Lab Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 14, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Dicaprylyl Carbonate, Dipropylene Glycol, PEG-10 Dimethicone, Disteardimonium Hectorite, Portulaca Oleracea Extract, Tocopheryl Acetate, Lavendula Angustifolia (Lavender) Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Cellulose Gum, Rosmarinus Officinalis (Rosmary) Leaf Extract, Althea Officinalis Leaf/Root Extract, Pyrus Malus (Apple) Fruit Water, Sodium Hyaluronate, Houttuynia Cordata Extract, Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Magnesium Sulfate, Methicone, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Dimethicone, Glyceryl Caprylate, Polyglyceryl-6 Polycinoleate, Microcrystalline Cellulose, Phenoxy Ethanol
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. ESLEE PHYSICAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82700-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.01248 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ROSEMARY (UNII: IJ67X351P9) ALTHAEA OFFICINALIS WHOLE (UNII: 8SG7244265) APPLE (UNII: B423VGH5S9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82700-0002-1 60 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/15/2022 Labeler - dr.eslee Lab Co., Ltd. (557804925) Registrant - dr.eslee Lab Co., Ltd. (557804925) Establishment Name Address ID/FEI Business Operations dr.eslee Lab Co., Ltd. 557804925 label(82700-0002) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611 manufacture(82700-0002)
