Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 14cff1a3-89b9-f4da-e063-6394a90a1a41
Route
TOPICAL
Published
Effective Date 2024-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (16 g)
Inactive Ingredients
Glycerin Glutamic Acid Phenoxyethanol Propanediol Brassica Napus Whole Histidine Monohydrochloride Proline Phenylalanine Sodium Chloride Palmitoyl Tripeptide-5 Hyaluronate Sodium Allantoin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Polyhydroxystearic Acid (2300 Mw) Xanthan Gum Bentonite Cetostearyl Alcohol Mecasermin Nepidermin Dimethicone Medium-chain Triglycerides Alanine Taurine Lactic Acid Honey Palmitoyl Tetrapeptide-7 Serine Lecithin, Soybean Maltodextrin Mannitol 1,2-hexanediol Threonine Isoleucine Folic Acid Cyclomethicone 5 Fibroblast Growth Factor-1 Glycine Caesalpinia Spinosa Fruit Pod Polysorbate 20 Basic Fibroblast Growth Factor (human) Acetyl Hexapeptide-8 Aceglutamide Leucine Water Helianthus Annuus Sprout Butylene Glycol Caprylyl Glycol Ethylhexylglycerin Mica Lysine Hydrochloride Arginine Valine Dimethylmethoxy Chromanyl Palmitate Citric Acid Monohydrate Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-29

Description

Active Ingredient: Zinc Oxide 16%


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

Use(s) • 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

Directions • apply liberally and evenly to face 15 minutes before sun exposure • use a water-resistant sunscreen if swimming or sweating • reapply 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 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-sleeve shirts, pants, hat and sunglasses • children under 6 months: Ask a doctor

Description

Active Ingredient: Zinc Oxide 16%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive Ingredients: Water, Brassica Napus Extract, Dimethicone, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Bentonite, Cetearyl Alcohol, Polyglyceryl-8 Oleate, Sodium Chloride, Peptide-Rich Plasma® (sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-9, sh-Polypeptide-11, Acetyl Hexapeptide-8, sh-Oligopeptide-1, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7, Acetyl Glutamine, Sodium Hyaluronate, Lysine HCL, Alanine, Histidine HCL, Arginine, Serine, Proline, Glutamic Acid, Threonine, Valine, Leucine, Glycine, Isoleucine, Phenylalanine, Taurine), Lactic Acid, Honey, Dimethylmethoxy Chromanyl Palmitate, Hydrolyzed Sodium Hyaluronate, Allantoin, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Bacillus/Folic Acid Ferment Filtrate Extract, Lecithin, Butylene Glycol, Maltodextrin, Mannitol, Xanthan Gum, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Citric Acid, Polysorbate 20, 1,2-Hexanediol, Polyhydroxystearic Acid, Phenoxyethanol, Ehtylhexylglycerin, Iron Oxides, Mica.

Section 51945-4

Section 55105-1

Purpose Sunscreen

Section 55106-9

Active Ingredient:

Zinc Oxide 16%

Section 60561-8

Other Information Protect this product from excessive heat & direct sun.


Structured Label Content

Indications and Usage (34067-9)

Use(s) • 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)

Directions • apply liberally and evenly to face 15 minutes before sun exposure • use a water-resistant sunscreen if swimming or sweating • reapply 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 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-sleeve shirts, pants, hat and sunglasses • children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

Warnings For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Brassica Napus Extract, Dimethicone, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Bentonite, Cetearyl Alcohol, Polyglyceryl-8 Oleate, Sodium Chloride, Peptide-Rich Plasma® (sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-9, sh-Polypeptide-11, Acetyl Hexapeptide-8, sh-Oligopeptide-1, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7, Acetyl Glutamine, Sodium Hyaluronate, Lysine HCL, Alanine, Histidine HCL, Arginine, Serine, Proline, Glutamic Acid, Threonine, Valine, Leucine, Glycine, Isoleucine, Phenylalanine, Taurine), Lactic Acid, Honey, Dimethylmethoxy Chromanyl Palmitate, Hydrolyzed Sodium Hyaluronate, Allantoin, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Bacillus/Folic Acid Ferment Filtrate Extract, Lecithin, Butylene Glycol, Maltodextrin, Mannitol, Xanthan Gum, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Citric Acid, Polysorbate 20, 1,2-Hexanediol, Polyhydroxystearic Acid, Phenoxyethanol, Ehtylhexylglycerin, Iron Oxides, Mica.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Sunscreen

Section 55106-9 (55106-9)

Active Ingredient:

Zinc Oxide 16%

Section 60561-8 (60561-8)

Other Information Protect this product from excessive heat & direct sun.


Advanced Ingredient Data


Raw Label Data

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