bfdba9a2-51dd-5c33-e053-2a95a90af654

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

Warnings

For external use only

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
Other Information
  • Protect this product from excessive heat and direct sun
  • may stain some fabrics
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.

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
Ask Doctor

Stop use and ask a doctor if rash develops

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.
Active Ingredients

Zinc Oxide 14%

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

Warnings

For external use only

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
Other Information
  • Protect this product from excessive heat and direct sun
  • may stain some fabrics
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.

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
Ask Doctor

Stop use and ask a doctor if rash develops

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.
Active Ingredients

Zinc Oxide 14%

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

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