SPL v4
SPL
SPL Set ID 252fdc91-bbe2-58ec-e063-6294a90a5067
Route
TOPICAL
Published
Effective Date 2025-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
C12-15 Alkyl Benzoate Coco-caprylate/caprate Ci 77499 Sodium Citrate Squalane Ci 77492 Lactic Acid Ethylhexyl Methoxycrylene Magnesium Aluminum Silicate Sodium Hydroxide Triethoxycaprylylsilane Hydroxyacetophenone Water Glyceryl Oleate Citrate Saccharide Isomerate Polyhydroxystearic Acid (2300 Mw) Diisopropyl Adipate Alpha-tocopherol Acetate Polyglyceryl-4 Isostearate Propanediol Caprylic/capric Triglyceride Citric Acid Decyl Glucoside Potassium Cetyl Phosphate Aluminum Starch Octenylsuccinate Phenoxyethanol Ammonium Polyacryloyldimethyl Taurate Ci 77491

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01
Description

ZINC OXIDE 20%

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 20%

Use

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

Section 50570-1

on damaged or broken skin

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 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
Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

ZINC OXIDE 20%

Inactive Ingredients



Water, Diisopropyl Adipate, Coco-Caprylate/Caprate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Glyceryl Oleate Citrate, Propanediol, Decyl Glucoside, Polyglyceryl-4 Isostearate, Squalane, Aluminum Starch Octenylsuccinate, Saccharide Isomerate, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Magnesium Aluminum Silicate, Citric Acid, Sodium Citrate, Hydroxyacetophenone, Potassium Cetyl Phosphate, Phenoxyethanol, Polyhydroxystearic Acid, Ammonium Polyacryloyldimethyl Taurate, Lactic Acid, Sodium Hydroxide, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)

Principal Display Panel

Ultra Violette

Future Screen Broad Spectrum SPF 50

1.7 FL. OZ. (50 mL)

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children

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

Structured Label Content

Use (USE)

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

Section 50570-1 (50570-1)

on damaged or broken skin

Purpose (PURPOSE)

SUNSCREEN

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 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
Other Information

Protect this product from excessive heat and direct sun

Active Ingredients (ACTIVE INGREDIENTS)

ZINC OXIDE 20%

Inactive Ingredients



Water, Diisopropyl Adipate, Coco-Caprylate/Caprate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Glyceryl Oleate Citrate, Propanediol, Decyl Glucoside, Polyglyceryl-4 Isostearate, Squalane, Aluminum Starch Octenylsuccinate, Saccharide Isomerate, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Magnesium Aluminum Silicate, Citric Acid, Sodium Citrate, Hydroxyacetophenone, Potassium Cetyl Phosphate, Phenoxyethanol, Polyhydroxystearic Acid, Ammonium Polyacryloyldimethyl Taurate, Lactic Acid, Sodium Hydroxide, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)

Principal Display Panel

Ultra Violette

Future Screen Broad Spectrum SPF 50

1.7 FL. OZ. (50 mL)

When Using This Product (WHEN USING THIS PRODUCT)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

rash occurs

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.384199 · Updated: 2026-03-14T23:12:28.058882