Label: DEW SKIN TINTED MOISTURIZER BROAD SPECTRUM SPF 20- zinc oxide lotion
- NDC Code(s): 69026-483-01
- Packager: Beauty Counter, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 3, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Uses
- Warnings
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Directions
- Apply as needed daily
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months: Ask a doctor.
- Sun Protection Measures Spending time in the sun increases the 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.
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Inactive ingredients
Water, Caprylic/Capric Triglyceride, Coco-Caprylate, Trimethylsiloxysilicate, Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Octyldodecyl Oleate, Ethylhexyl Palmitate, Isopropyl Myristate, Dimethicone, Magnesium Sulfate, Beeswax, Gluconolactone, Glycerin, Isoeicosane, Propanediol, Hydrogenated Castor Oil, Sodium Chloride, Ribes Nigrum (Black Currant) Seed Oil, Octyldodecanol, Tetrahexyldecyl Ascorbate, Sodium Benzoate, Prunus Amygdalus Dulcis (Sweet Almond) Oil,
Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Octyldodecyl Stearoyl Stearate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Paeonia Suffruticosa Root Extract, Calcium Gluconate, Rosa Damascena Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Salvia Sclarea (Clary) Oil, Vanilla Planifolia Fruit, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgaurea (Goldenrod) Extract ,Tocopherol ,Sodium Hyaluronate , May Contain (+/-): Titanium Dioxide (CI 77891) Yellow Iron Oxide (CI 77492) Iron Oxides (CI 77491) Iron Oxide (CI 77499) Mica (CI 77019) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEW SKIN TINTED MOISTURIZER BROAD SPECTRUM SPF 20
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69026-483 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 14 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE (UNII: 4828G836N6) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) ETHYLHEXYL PALMITATE (UNII: 2865993309) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) YELLOW WAX (UNII: 2ZA36H0S2V) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) ISOEICOSANE (UNII: AR294KAG3T) PROPANEDIOL (UNII: 5965N8W85T) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SODIUM CHLORIDE (UNII: 451W47IQ8X) BLACK CURRANT (UNII: 9755T40D11) OCTYLDODECANOL (UNII: 461N1O614Y) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SODIUM BENZOATE (UNII: OJ245FE5EU) ALMOND OIL (UNII: 66YXD4DKO9) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) BERGAMOT OIL (UNII: 39W1PKE3JI) ALCOHOL (UNII: 3K9958V90M) ORANGE OIL (UNII: AKN3KSD11B) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) CALCIUM GLUCONATE (UNII: SQE6VB453K) ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) ORANGE PEEL (UNII: TI9T76XD44) CLARY SAGE OIL (UNII: 87L0D4U3M0) VANILLA PLANIFOLIA WHOLE (UNII: BOS0R5Y21O) ROSEMARY OIL (UNII: 8LGU7VM393) SOLIDAGO VIRGAUREA WHOLE (UNII: F45YHM06JE) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69026-483-01 1 in 1 CARTON 12/01/2021 1 40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2021 Labeler - Beauty Counter, LLC (070346240)
