1989370f-68a6-6f22-e063-6394a90aacaf

SPL v3
SPL
SPL Set ID 1989370f-68a6-6f22-e063-6394a90aacaf
Route
topical
Published
Effective Date 2024-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (20 g)
Inactive Ingredients
ethylhexyl olivate coco-glycerides water alkyl (c12-15) benzoate tocopherol sodium citrate, unspecified form c9-12 alkane pentylene glycol butylene glycol avocado oil trihydroxystearin triethyl citrate sunflower oil phaeodactylum tricornutum disteardimonium hectorite polymethylsilsesquioxane (4.5 microns) beta vulgaris root fructooligosaccharides lecithin, soybean polyhydroxystearic acid (2300 mw) spirulina maxima propanediol hydrogenated jojoba oil, randomized squalane hydroxyacetophenone caprylhydroxamic acid dimethicone medium-chain triglycerides caprylyl glycol borosilicate glass butyloctyl salicylate betaine sucrose sodium chloride tetrasodium glutamate diacetate sodium dehydroacetate ferric oxide red

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-15

Boxed Warning
For external use only. • 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 rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications and Usage

• Apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • 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 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • For children under 6 months of age: Ask a doctor

Dosage and Administration

Cream

Purpose

Sunscreen

Description

Zinc Oxide 20%........................ Sunscreen


Medication Information

Boxed Warning

For external use only. • 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 rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only. Avoid contact with eyes. Do not apply to damaged or irritated skin. If irritation or redness occurs, discontinue use.

Indications and Usage

• Apply liberally 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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 a.m. - 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses

• For children under 6 months of age: Ask a doctor

Purpose

Sunscreen

Dosage and Administration

Cream

Inactive Ingredients

Water (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract,

Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural).

Description

Zinc Oxide 20%........................ Sunscreen

Otc Purpose

Sunscreen

Boxed Warnings

For external use only. • 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 rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Principal Display

DRUG FACTS

Active Ingredients Purpose

Zinc Oxide 20%........................ Sunscreen

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. • 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 rash occurs. • 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 at least every 2 hours

• use a water-resistant sunscreen

if swimming or sweating

• 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 a.m. - 2 p.m.

• Wear long-sleeved shirts, pants,

hats, and sunglasses

• For children under 6 months of age:

Ask a doctor

Inactive Ingredients:

Water (Aqua), Ethylhexyl Olivate, C9-12

Alkane, Hydroxyethyl Dimethicone

Laurate, Propanediol, Calcium Sodium

Borosilicate, Pentylene Glycol,

Polymethylsilsesquioxane, Butylene Glycol,

Butyloctyl Salicylate, C12-15 Alkyl

Benzoate, Cocoglycerides, Jojoba Esters,

Dimethicone, Betaine, Sucrose, Spirulina

Maxima Extract, Fructooligosaccharides,

Beta Vulgaris (Beet) Root Extract,

Hydrolyzed Rhodophyceae Extract,

Helianthus Annuus (Sunflower) Seed Oil,

Phaeodactylum Tricornutum Extract,

Dipotassium Glycyrrhizate, Persea

Gratissima (Avocado) Oil, Squalane,

Caprylic/Capric Triglyceride, Tocopherol,

Lecithin, Hydroxyacetophenone,

Disteardimonium Hectorite,

Polyhydroxystearic Acid,

Trihydroxystearin, Triethyl Citrate, Caprylyl

Glycol, Tetrasodium Glutamate Diacetate,

Sodium Dehydroacetate, Hydrogenated

Vegetable Oil, Caprylhydroxamic Acid,

Sodium Chloride, Sodium Citrate, Iron

Oxides (CI 77492), Iron Oxides (CI 77491),

Fragrance (Natural).

Other Information

Protect the product in this container from

excessive heat and direct sun.

Active Ingredients

Zinc Oxide 20%........................ Sunscreen

Otc Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Warnings

For external use only. Avoid contact with eyes. Do not apply to damaged or irritated skin. If irritation or redness occurs, discontinue use.

Indications and Usage

• Apply liberally 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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 a.m. - 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses

• For children under 6 months of age: Ask a doctor

Dosage and Administration

Cream

Inactive Ingredients

Water (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract,

Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural).

Otc Purpose (OTC - Purpose)

Sunscreen

Boxed Warnings

For external use only. • 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 rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Principal Display

DRUG FACTS

Active Ingredients Purpose

Zinc Oxide 20%........................ Sunscreen

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. • 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 rash occurs. • 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 at least every 2 hours

• use a water-resistant sunscreen

if swimming or sweating

• 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 a.m. - 2 p.m.

• Wear long-sleeved shirts, pants,

hats, and sunglasses

• For children under 6 months of age:

Ask a doctor

Inactive Ingredients:

Water (Aqua), Ethylhexyl Olivate, C9-12

Alkane, Hydroxyethyl Dimethicone

Laurate, Propanediol, Calcium Sodium

Borosilicate, Pentylene Glycol,

Polymethylsilsesquioxane, Butylene Glycol,

Butyloctyl Salicylate, C12-15 Alkyl

Benzoate, Cocoglycerides, Jojoba Esters,

Dimethicone, Betaine, Sucrose, Spirulina

Maxima Extract, Fructooligosaccharides,

Beta Vulgaris (Beet) Root Extract,

Hydrolyzed Rhodophyceae Extract,

Helianthus Annuus (Sunflower) Seed Oil,

Phaeodactylum Tricornutum Extract,

Dipotassium Glycyrrhizate, Persea

Gratissima (Avocado) Oil, Squalane,

Caprylic/Capric Triglyceride, Tocopherol,

Lecithin, Hydroxyacetophenone,

Disteardimonium Hectorite,

Polyhydroxystearic Acid,

Trihydroxystearin, Triethyl Citrate, Caprylyl

Glycol, Tetrasodium Glutamate Diacetate,

Sodium Dehydroacetate, Hydrogenated

Vegetable Oil, Caprylhydroxamic Acid,

Sodium Chloride, Sodium Citrate, Iron

Oxides (CI 77492), Iron Oxides (CI 77491),

Fragrance (Natural).

Other Information

Protect the product in this container from

excessive heat and direct sun.

Active Ingredients

Zinc Oxide 20%........................ Sunscreen

Otc Keep Out of Reach of Children (OTC - Keep out of reach of Children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)