Counter Beauty Dew Skin Tinted Moisturizer No. 8

Counter Beauty Dew Skin Tinted Moisturizer No. 8
SPL v1
SPL
SPL Set ID 3a362e05-3a1e-8059-e063-6294a90ad525
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14 g)
Inactive Ingredients
Prunus Amygdalus Dulcis (sweet Almond) Oil Solidago Virgaurea Whole Dimethicone 100 Calcium Gluconate Isopropyl Myristate Gluconolactone Ribes Nigrum (black Currant) Seed Oil Trimethylsiloxysilicate (m/q 0.6-0.8) Sodium Chloride Hydrogenated Castor Oil Sodium Benzoate Octyldodecanol Rosmarinus Officinalis (rosemary) Leaf Powder Isostearic Acid Octyldodecyl Stearoyl Stearate Citrus Aurantium Dulcis (orange) Flower Oil Polyhydroxystearic Acid (2300 Mw) Tetrahexyldecyl Ascorbate Polyglyceryl-3 Ricinoleate Ci 77492 Magnesium Sulfate Isoeicosane Propanediol Ci 77491 Ethylhexyl Palmitate Coco-caprylate Sodium Hyaluronate Beeswax Titanium Dioxide Water Citrus Aurantium Bergamia (bergamot) Fruit Oil Mica Lecithin, Soybean Citrus Aurantium Dulcis (orange) Peel Oil Salvia Sclarea (clary) Oil Isopropyl Palmitate Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Octyldodecyl Oleate Rosa Damascena Flower Oil Tocopherol Caprylic/capric Triglyceride Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Glycerin Alcohol Paeonia Suffruticosa Root Vanilla Planifolia Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
Description

Zinc Oxide 14.0%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • 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.
Dosage and Administration
  • 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.​​
Description

Zinc Oxide 14.0%

Section 50565-1

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

Section 50566-9

rash occurs.

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Section 50570-1

On damaged or broken skin.

Section 51727-6

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)

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 14.0%

Section 60561-8
  • Protect the product in this container from excessive heat or direct sun.

Structured Label Content

Indications and Usage (34067-9)
  • 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.
Dosage and Administration (34068-7)
  • 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.​​
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

rash occurs.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

On damaged or broken skin.

Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 14.0%

Section 60561-8 (60561-8)
  • Protect the product in this container from excessive heat or direct sun.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:33.879205 · Updated: 2026-03-14T23:09:25.529071