FDA.reportPublic FDA data

Beauty Counter Dew Skin Moisturizer Medium

Manufacturer
Beauty Counter, LCC
Effective date
2022-11-03
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:49:43

Label at a glance#

ProductBeauty Counter Dew Skin Moisturizer Medium SPF 20
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn if used as directed witho other sun production measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Children under 6 months of age: Ask a doctor. Sun Protection Measures Spending time in the sun increases you 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 10AM-2PM Wear long sleeved shirts, pants,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide - 14%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • if used as directed witho other sun production measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and aks a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: Ask a doctor.
  • Sun Protection Measures

Spending time in the sun increases you 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 10AM-2PM
  • Wear long sleeved shirts, pants, hats and sunglasses
  • Reapply at leat every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

Other Information

OTHER SAFETY INFORMATION

  • Store at temperatures below 90°F.
  • Protect this product from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Coc-Caprylate, Trimethylsiloxysilicate, Isoprpyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Palmitate, Isoproyl Myristate, Octyldodecyl Oleate, Dimethicone, Magnesium Sulfate, Beeswax, Glucolactone, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Sodium Hyaluronate, Sodium Chloride, Glycerin, Propanediol, Sodium Benzoate, Isoeicosane, Hydrogenated Castor Oil, Tetrahexyldecyl Ascorbate, Ribes Nigrum (Black Currant) Seed Oil, Octyldodecanol, Octyldodecyl Stearoyl Stearate,  Alcohol, Paeonia Suffruticosa (Peony) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgqurea (Goldenrod) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Citrus Aurantium Dulcis (Orange) Oil, Rosa Damascena (Rose) Flower Oil, Salvia Sclarea (Clary) Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Vanilla Planifolia Fruit Extract, Silica, Titanium Dioxide, Iron Oxides, Mica.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dew Skin cartonDew Skin carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
ZINC CATIONACTIVE MOIETY13S1S8SF372
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
BERGAMOT OILINACTIVE INGREDIENT39W1PKE3JI2
CITRUS SINENSIS FLOWER OILINACTIVE INGREDIENTAJ56JP5TFP2
CLARY SAGE OILINACTIVE INGREDIENT87L0D4U3M02
COCO-CAPRYLATEINACTIVE INGREDIENT4828G836N62
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C52
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933092
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY2
ISOEICOSANEINACTIVE INGREDIENTAR294KAG3T2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00622
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
MICAINACTIVE INGREDIENTV8A1AW08802
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y2
OCTYLDODECYL OLEATEINACTIVE INGREDIENTMCA43PK7MH2
OCTYLDODECYL STEAROYL STEARATEINACTIVE INGREDIENT3D47Q6D93C2
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B2
PAEONIA SUFFRUTICOSA ROOTINACTIVE INGREDIENT7M7E9A2C8J2
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W2
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S72
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F2
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T2
RIBES NIGRUM SEED OILINACTIVE INGREDIENTGKE11888372
ROSA DAMASCENA FLOWER OILINACTIVE INGREDIENT18920M3T132
ROSEMARYINACTIVE INGREDIENTIJ67X351P92
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SOLIDAGO VIRGAUREA FLOWERING TOPINACTIVE INGREDIENT5405K23S502
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)INACTIVE INGREDIENT25LXE464L22
VANILLAINACTIVE INGREDIENTQ74T35078H2
waterINACTIVE INGREDIENT059QF0KO0R2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69026-28169026-281-01, 69026-281-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
YELLOW WAX2ZA36H0S2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BERGAMOT OIL39W1PKE3JIIACT
CITRUS SINENSIS FLOWER OILAJ56JP5TFPIACT
ORANGE OILAKN3KSD11BIACT
COCO-CAPRYLATE4828G836N6IACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ETHYLHEXYL PALMITATE2865993309IACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ISOEICOSANEAR294KAG3TIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISOSTEARIC ACIDX33R8U0062IACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
OCTYLDODECANOL461N1O614YIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
PAEONIA SUFFRUTICOSA ROOT7M7E9A2C8JIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
ALMOND OIL66YXD4DKO9IACT
RIBES NIGRUM SEED OILGKE1188837IACT
ROSA DAMASCENA FLOWER OIL18920M3T13IACT
ROSEMARYIJ67X351P9IACT
CLARY SAGE OIL87L0D4U3M0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
VANILLAQ74T35078HIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 550 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL / TOPICAL9.3 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BLIQUID / ORAL50 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVINJECTION, EMULSION / INTRAVENOUS12852 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / ORAL232 mgExact identifier — unii candidate
12 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE / ORAL405 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BELIXIR / ORAL0.24 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ec963123-4b6a-6828-e053-2a95a90a0d9b1cb4b3b8-5008-4e09-bc5a-c8b49d2c06642022-11-03WarningsExact identifier
spl id: ec963123-4b6a-6828-e053-2a95a90a0d9b
spl set id: 1cb4b3b8-5008-4e09-bc5a-c8b49d2c0664

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.