SPL v5
SPL
SPL Set ID bfdba9a2-51dd-5c33-e053-2a95a90af654
Route
TOPICAL
Published
Effective Date 2021-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14 g)
Inactive Ingredients
Aloe Vera Leaf Bentonite Levomenol Butyloctyl Salicylate Caprylhydroxamic Acid Medium-chain Triglycerides Caprylyl Glycol Safflower Oil Carboxymethylcellulose Sodium Cetostearyl Alcohol Coco Glucoside Glycerin Sunflower Oil Jojoba Oil, Randomized Methyl Dihydroabietate Microcrystalline Cellulose Polyhydroxystearic Acid (2300 Mw) Tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-13
Description

Zinc Oxide 14%

Medication Information

Description

Zinc Oxide 14%

Section 51945-4

SPF 30 Sunscreen Spray NDC: 81757-002-06

Section 55105-1

Uses

  • 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
Warnings

For external use only

Ask Doctor

Stop use and ask a doctor if rash develops

Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Spray on hands and apply to face
  • use in well-ventilated area
  • do not inhale
  • children under 6 months: ask a doctor

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 Broad Spectrum value of 15 or higher along with other sun protection measures including:

  • limit time in the sun, especially from 10a.m. - 2 p.m.
  • wear long sleeved shirts, pants, hats and sunglasses
Do Not Use

On damaged or broken skin

When Using
  • When using this product keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 degrees F.
Other Information
  • Protect this product from excessive heat and direct sun
  • may stain some fabrics
Active Ingredients

Zinc Oxide 14%

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 Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Tocopherol, Water.

Questions Or Comments?

1-833-909-2662 Monday - Friday 9am-5pm MST

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.

Structured Label Content

Section 51945-4 (51945-4)

SPF 30 Sunscreen Spray NDC: 81757-002-06

Section 55105-1 (55105-1)

Uses

  • 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
Warnings

For external use only

Ask Doctor

Stop use and ask a doctor if rash develops

Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Spray on hands and apply to face
  • use in well-ventilated area
  • do not inhale
  • children under 6 months: ask a doctor

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 Broad Spectrum value of 15 or higher along with other sun protection measures including:

  • limit time in the sun, especially from 10a.m. - 2 p.m.
  • wear long sleeved shirts, pants, hats and sunglasses
Do Not Use (Do not use)

On damaged or broken skin

When Using (When using)
  • When using this product keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 degrees F.
Other Information
  • Protect this product from excessive heat and direct sun
  • may stain some fabrics
Active Ingredients

Zinc Oxide 14%

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 Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Tocopherol, Water.

Questions Or Comments? (Questions or Comments?)

1-833-909-2662 Monday - Friday 9am-5pm MST

Keep Out of Reach of Children (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: 2026-02-15T11:59:32.261225 · Updated: 2026-03-14T22:59:32.588894