45b486cf-28ee-6392-e063-6394a90affb0

SPL v2
SPL
SPL Set ID 45b486cf-28ee-6392-e063-6394a90affb0
Route
topical
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (24.78 g)
Inactive Ingredients
carthamus tinctorius (safflower) seed oil helianthus annuus (sunflower) seed oil bisabolol tocopherol microcrystalline cellulose caprylyl glycol caprylhydroxamic acid butyloctyl salicylate cellulose gum cetearyl alcohol hydrogenated jojoba oil, randomized methyl dihydroabietate polyhydroxystearic acid (2300 mw) water caprylic/capric triglyceride coco-glucoside glycerin aloe barbadensis leaf juice bentonite

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-15
Description

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Warnings • For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames. Protect this product from excessive heat and direct sun Do not use on damaged or broken skin When using this product keep out of eyes • Rinse with water to remove. Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor. Sun Protection Measure: 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.to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses

Medication Information

Warnings and Precautions

Warnings

• For external use only - Flammable Do not spray near heat, sparks, sources of ignition, or flames. Protect this product from excessive heat and direct sun

  • Do not use on damaged or broken skin
  • When using this product keep out of eyes

    Rinse with water to remove.
  • Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.
  • Keep out of reach of children

lf product is swallowed, get medical help or contact a Poison Control Center right away

Active Ingredient

Active Ingredient Zinc Oxide - 14.0%

Indications and Usage

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only

  • Flammable Do not spray near heat, sparks, sources of ignition, or flames.
  • Protect this product from excessive heat and direct sun
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes • Rinse with water to remove.
  • Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.

Keep out of reach of children

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

Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor.

Sun Protection Measure: 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.to 2 p.m.

Wear long-sleeved shirts, pants, hats, and sun glasses

Dosage and Administration

Directions Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day or after swimming or sweating. • Children under 6 months: ask a doctor.

Description

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Warnings • For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames. Protect this product from excessive heat and direct sun Do not use on damaged or broken skin When using this product keep out of eyes • Rinse with water to remove. Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor. Sun Protection Measure: 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.to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses

Section 50565-1

Keep out of reach of children

lf product is swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower)

Seed Oil, Cellulose Gum, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Helianthus Annuus (Sunflower) Oil, Jojoba Esters, Methyl Dihydroabetate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Tocopherol, Water.

Section 51945-4

Resource Essentials

Sun Protection Mineral Spray

SPF 30

Net Wt. 6 oz (177 mL)

Resource Essentials

Sun Protection Mineral Spray

SPF 30

Net Wt. 6 oz (177 mL)

Section 55105-1

Sunscreen

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

• For external use only - Flammable Do not spray near heat, sparks, sources of ignition, or flames. Protect this product from excessive heat and direct sun

  • Do not use on damaged or broken skin
  • When using this product keep out of eyes

    Rinse with water to remove.
  • Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.
  • Keep out of reach of children

lf product is swallowed, get medical help or contact a Poison Control Center right away

Active Ingredient (55106-9)

Active Ingredient Zinc Oxide - 14.0%

Indications and Usage (34067-9)

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only

  • Flammable Do not spray near heat, sparks, sources of ignition, or flames.
  • Protect this product from excessive heat and direct sun
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes • Rinse with water to remove.
  • Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.

Keep out of reach of children

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

Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor.

Sun Protection Measure: 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.to 2 p.m.

Wear long-sleeved shirts, pants, hats, and sun glasses

Dosage and Administration (34068-7)

Directions Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day or after swimming or sweating. • Children under 6 months: ask a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children

lf product is swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower)

Seed Oil, Cellulose Gum, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Helianthus Annuus (Sunflower) Oil, Jojoba Esters, Methyl Dihydroabetate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Tocopherol, Water.

Section 51945-4 (51945-4)

Resource Essentials

Sun Protection Mineral Spray

SPF 30

Net Wt. 6 oz (177 mL)

Resource Essentials

Sun Protection Mineral Spray

SPF 30

Net Wt. 6 oz (177 mL)

Section 55105-1 (55105-1)

Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:56.514165 · Updated: 2026-03-14T23:11:59.437858