Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID cd35ae20-d5b7-479d-8a5e-0278eae9e83c
Route
TOPICAL
Published
Effective Date 2023-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (18 mg)
Inactive Ingredients
Water Diisocetyl Adipate Butyloctyl Salicylate Propanediol Glycerin Cetearyl Olivate Polyhydroxystearic Acid (2300 Mw) Sorbitan Olivate .beta.-bisabolol Pongamia Pinnata Seed Zingiber Officinale Whole Tetrahydrodiferuloylmethane Tetrahydrodemethoxydiferuloylmethane Tetrahydrobisdemethoxydiferuloylmethane Calendula Officinalis Flower Camellia Sinensis Seed Matricaria Chamomilla Flowering Top Centella Asiatica Phenoxyethanol Polyglyceryl-4 Laurate/succinate Lauroyl Lysine Triethoxycaprylylsilane Arachidyl Alcohol Silicon Xanthan Gum Potassium Cetyl Phosphate Caprylyl Glycol Vinylpyrrolidone/eicosene Copolymer Arachidyl Glucoside Tetrasodium Glutamate Diacetate Ethylhexylglycerin Cetyl Alcohol Stannic Oxide Isononyl Isononanoate Sorbitan Monooleate Titanium Dioxide Mica Brown Iron Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-21

Description

Zinc Oxide 18%


Medication Information

Description

Zinc Oxide 18%

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

Prupose

Sunscreen

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 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

• children under 6 months of age: Ask a doctor

Questions?

Visit prequelskin.com

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 18%

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

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

Prupose

Sunscreen

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 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

• children under 6 months of age: Ask a doctor

Questions?

Visit prequelskin.com

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 18%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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