2392c772-c251-1597-e063-6394a90a52f2

SPL v2
SPL
SPL Set ID 2392c772-c251-1597-e063-6394a90a52f2
Route
topical
Published
Effective Date 2021-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (15.45 g)
Inactive Ingredients
sodium chloride glycerin propanediol levomenol stearoyl glutamic acid potassium sorbate gluconolactone rosemary water coco-caprylate/caprate polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate calendula officinalis flower propylene carbonate citric acid monohydrate tocopherol alkyl (c12-15) benzoate glycyrrhizinate dipotassium stearalkonium hectorite sunflower oil butyloctyl salicylate cannabidiol xanthan gum lingonberry cannabis sativa seed oil c9-12 alkane sodium benzoate isododecane octyldodecanol rice bran castor oil/ipdi copolymer calcium gluconate dilinoleic acid/butanediol copolymer polyhydroxystearic acid (2300 mw) hydroxyacetophenone medium-chain triglycerides butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) triheptanoin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2021-04-27
Description

Zinc Oxide 15.45

Medication Information

Warnings and Precautions
  • For external use only.
Active Ingredient
  • Zinc Oxide 15.45
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
  • Shake well & apply liberally to face & neck using a gentle upward motion prior to sun exposure.

For Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Not for use on children.

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.
Description

Zinc Oxide 15.45

Section 50565-1
  • If swallowed, get medical help or contact a Poison Control Center.
Section 50566-9
  • if 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/Aqua/Eau, Isododecane, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Acrylates Copolymer, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Propanediol, Cannabis Sativa Seed Oil, Sodium Chloride, Polyhydroxystearic Acid, Cannabidiol, Triheptanoin, Stearalkonium Hectorite, Calendula Officinalis Flower Extract, Stearoyl Glutamic Acid, Hydroxyacetophenone, Xanthan Gum, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Propylene Carbonate, Sodium Benzoate, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea Fruit Extract, Potassium Sorbate, Bisabolol, Oryza Sativa (Rice) Bran Extract, Castor Oil/IPDI Copolymer, Octyldodecanol, Helianthus Annuus (Sunflower) Extract, Citric Acid, Gluconolactone, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Calcium Gluconate

Section 51945-4

Section 53413-1
  • 1-888-823-7837
Section 53414-9
  • Not suitable for pregnant or lactating women.
Section 55105-1
  • Sunscreen
Section 60561-8
  • Protect the product in this container from excessive heat and direct sun.

Structured Label Content

Warnings and Precautions (34071-1)
  • For external use only.
Active Ingredient (55106-9)
  • Zinc Oxide 15.45
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)
  • Shake well & apply liberally to face & neck using a gentle upward motion prior to sun exposure.

For Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Not for use on children.

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.
Section 50565-1 (50565-1)
  • If swallowed, get medical help or contact a Poison Control Center.
Section 50566-9 (50566-9)
  • if 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/Aqua/Eau, Isododecane, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Acrylates Copolymer, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Propanediol, Cannabis Sativa Seed Oil, Sodium Chloride, Polyhydroxystearic Acid, Cannabidiol, Triheptanoin, Stearalkonium Hectorite, Calendula Officinalis Flower Extract, Stearoyl Glutamic Acid, Hydroxyacetophenone, Xanthan Gum, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Propylene Carbonate, Sodium Benzoate, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea Fruit Extract, Potassium Sorbate, Bisabolol, Oryza Sativa (Rice) Bran Extract, Castor Oil/IPDI Copolymer, Octyldodecanol, Helianthus Annuus (Sunflower) Extract, Citric Acid, Gluconolactone, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Calcium Gluconate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
  • 1-888-823-7837
Section 53414-9 (53414-9)
  • Not suitable for pregnant or lactating women.
Section 55105-1 (55105-1)
  • Sunscreen
Section 60561-8 (60561-8)
  • Protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:55.911309 · Updated: 2026-03-14T23:13:25.872506