SPL v2
SPL
SPL Set ID 2eeac795-b74e-b3a3-e063-6294a90abf52
Route
TOPICAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (155.2 mg)
Inactive Ingredients
Citronellol Benzotriazolyl Dodecyl P-cresol Glycerin Niacinamide Caprylic/capric Triglyceride Citrus Aurantium Bergamia (bergamot) Fruit Oil Polyglyceryl-6 Polyricinoleate Amyris Balsamifera Oil Water Cyclopentasiloxane Dipropylene Glycol Santalum Album (sandalwood) Oil Nutmeg Dimethicone Sodium Citrate Pelargonium Graveolens Flower Oil Cananga Odorata Flower Oil Boswellia Carterii Oil Tocopherol Limonene, (+)- Linalool Citral Distearyldimonium Chloride Isostearic Acid Dimethicone/polyglycerin-3 Crosspolymer Ricinus Communis (castor) Seed Oil Juniperus Virginiana Oil Paeonol Disteardimonium Hectorite Panthenol 1,2-hexanediol Magnesium Sulfate Triethoxycaprylylsilane Citrus Aurantifolia (lime) Oil Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-10

Description

Zinc Oxide 15.52%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and Administration

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

Description

Zinc Oxide 15.52%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

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
Do Not Use

Do not use on damaged or broken skin

Questions?

1-866-993-4709

When Using

When using this proudct keep out of eyes. Rinse with water to remove.

Active Ingredient

Zinc Oxide 15.52%

Other Information
  • protect the product in this container from excessive heat and direct sun
  • the proudct may stain certain types of fabrics
Inactive Ingredients

WATER, DIMETHICONE, BENZOTRIAZOLYL DODECYL P-CRESOL, CYCLOPENTASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIPROPYLENE GLYCOL, GLYCERIN, DISTEARDIMONIUM HECTORITE, 1,2-HEXANEDIOL, ISOSTEARIC ACID, MAGNESIUM SULFATE, PANTHENOL, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, TRIETHOXYCAPRYLYLSILANE, DISTEARYLDIMONIUM CHLORIDE, CITRUS AURANTIFOLIA (LIME) OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, AMYRIS BALSAMIFERA BARK OIL, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, RICINUS COMMUNIS (CASTOR) SEED OIL, CANANGA ODORATA FLOWER OIL, SANTALUM ALBUM (SANDALWOOD) OIL, JUNIPERUS VIRGINIANA OIL, BOSWELLIA CARTERII OIL, SODIUM CITRATE, TOCOPHEROL, PAEONOL, PAEONIA SUFFRUTICOSA BRANCH/FLOWER/LEAF EXTRACT, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL

Keep Out of Reach of Children.

Keep out of reach of children.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Dosage and Administration (34068-7)

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

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
Do Not Use (Do not use)

Do not use on damaged or broken skin

Questions?

1-866-993-4709

When Using (When using)

When using this proudct keep out of eyes. Rinse with water to remove.

Active Ingredient (Active ingredient)

Zinc Oxide 15.52%

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • the proudct may stain certain types of fabrics
Inactive Ingredients

WATER, DIMETHICONE, BENZOTRIAZOLYL DODECYL P-CRESOL, CYCLOPENTASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIPROPYLENE GLYCOL, GLYCERIN, DISTEARDIMONIUM HECTORITE, 1,2-HEXANEDIOL, ISOSTEARIC ACID, MAGNESIUM SULFATE, PANTHENOL, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, TRIETHOXYCAPRYLYLSILANE, DISTEARYLDIMONIUM CHLORIDE, CITRUS AURANTIFOLIA (LIME) OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, AMYRIS BALSAMIFERA BARK OIL, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, RICINUS COMMUNIS (CASTOR) SEED OIL, CANANGA ODORATA FLOWER OIL, SANTALUM ALBUM (SANDALWOOD) OIL, JUNIPERUS VIRGINIANA OIL, BOSWELLIA CARTERII OIL, SODIUM CITRATE, TOCOPHEROL, PAEONOL, PAEONIA SUFFRUTICOSA BRANCH/FLOWER/LEAF EXTRACT, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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