package labeling:

package labeling:
SPL v2
SPL
SPL Set ID ad2d3549-11d2-d5b7-e053-2995a90a8969
Route
topical
Published
Effective Date 2020-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Zinc Oxide (15%)


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Zinc Oxide (15%)

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

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  • 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 of 15 or higher and other sun protection measure including: • limit time in the sun, especially from 10 A.M.-2 P.M. • wear long-sleeve shirts, pants, hats and sunglasses • children under 6 months: Ask a doctor Sun Protection Measures: 

Description

Zinc Oxide (15%)

Section 42229-5

Protect this product from excessive heat and direct sun

Section 50565-1

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

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, Coco-caprylate/caprate, Vitis Vinifera (Grape) Seed Oil, C15-19 Alkane, Isocetyl Stearoyl Stearate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Sodium Hyaluronate Crosspolymer, Jojoba Esters, Tribehenin, Beeswax, Glyceryl Stearate, Leuconostoc/ Radish Root Ferment Filtrate, Glycerin, Lactobacillus, Acacia Senegal Gum, Xanthan Gum, Viola Tricolor Extract, Bisabolol, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract. May Contain: Titanium Dioxide, Iron Oxides, Mica.

Section 51945-4

Box2

Section 53413-1

Call 877-SAIE-HEY Monday-Friday from 10 A.M.-6 P.M. EST

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Zinc Oxide (15%)

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)

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  • 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 of 15 or higher and other sun protection measure including: • limit time in the sun, especially from 10 A.M.-2 P.M. • wear long-sleeve shirts, pants, hats and sunglasses • children under 6 months: Ask a doctor Sun Protection Measures: 

Section 42229-5 (42229-5)

Protect this product from excessive heat and direct sun

Section 50565-1 (50565-1)

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

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, Coco-caprylate/caprate, Vitis Vinifera (Grape) Seed Oil, C15-19 Alkane, Isocetyl Stearoyl Stearate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Sodium Hyaluronate Crosspolymer, Jojoba Esters, Tribehenin, Beeswax, Glyceryl Stearate, Leuconostoc/ Radish Root Ferment Filtrate, Glycerin, Lactobacillus, Acacia Senegal Gum, Xanthan Gum, Viola Tricolor Extract, Bisabolol, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract. May Contain: Titanium Dioxide, Iron Oxides, Mica.

Section 51945-4 (51945-4)

Box2

Section 53413-1 (53413-1)

Call 877-SAIE-HEY Monday-Friday from 10 A.M.-6 P.M. EST

Section 55105-1 (55105-1)

Sunscreen


Raw Label Data

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