package labeling:

package labeling:
SPL v3
SPL
SPL Set ID 68b8198d-7c46-458c-bfb9-9dbc968176ab
Route
topical
Published
Effective Date 2022-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Zinc Oxide 19 %


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Zinc Oxide 19 %

Indications and Usage

Helps prevent sunburn

Dosage and Administration

• Apply generously and evenly 15 minutes before sun exposure. • 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 am - 2 pm • wear long-sleeved shirts, pants, hats, and sunglasses. • For use on children less than 6 months of age, consult a doctor

Description

Zinc Oxide 19 %

Section 42229-5

• Protect the product in this container from excessive heat and direct sun. • Store at 15-30°C (59-86°F).

Section 50565-1

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

Section 50567-7

keep out of eyes. Rinse with water to remove. Discontinue use and ask a doctor if rash occurs

Section 50570-1

on damaged or broken skin

Section 51727-6

Water, Coco-Caprylate, Caprylic/ Capric Triglyceride, Cetearyl Isononanoate, Ethylhexyl Palmitate, Glycerin, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Isopropyl Myristate, Magnesium Sulfate, Tocopherol, Polyglyceryl-3 Polyricinoleate, Decylene Glycol, Camellia Sinensis Leaf Extract, Lecithin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunfl ower) Seed Oil, 1,2-Hexanediol, Xanthan Gum, Hydrogenated Castor Oil, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera/Cire de candelilla, Sodium Chloride, Isostearic Acid, Silica, Polyhydroxystearic Acid, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Citric Acid.

Section 51945-4

Label01

Section 53413-1

CAN: 1-800-361-2746 / USA 1-800-321-3434.

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Zinc Oxide 19 %

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

• Apply generously and evenly 15 minutes before sun exposure. • 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 am - 2 pm • wear long-sleeved shirts, pants, hats, and sunglasses. • For use on children less than 6 months of age, consult a doctor

Section 42229-5 (42229-5)

• Protect the product in this container from excessive heat and direct sun. • Store at 15-30°C (59-86°F).

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove. Discontinue use and ask a doctor if rash occurs

Section 50570-1 (50570-1)

on damaged or broken skin

Section 51727-6 (51727-6)

Water, Coco-Caprylate, Caprylic/ Capric Triglyceride, Cetearyl Isononanoate, Ethylhexyl Palmitate, Glycerin, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Isopropyl Myristate, Magnesium Sulfate, Tocopherol, Polyglyceryl-3 Polyricinoleate, Decylene Glycol, Camellia Sinensis Leaf Extract, Lecithin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunfl ower) Seed Oil, 1,2-Hexanediol, Xanthan Gum, Hydrogenated Castor Oil, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera/Cire de candelilla, Sodium Chloride, Isostearic Acid, Silica, Polyhydroxystearic Acid, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Citric Acid.

Section 51945-4 (51945-4)

Label01

Section 53413-1 (53413-1)

CAN: 1-800-361-2746 / USA 1-800-321-3434.

Section 55105-1 (55105-1)

Sunscreen


Raw Label Data

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