Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24h Fps 12

SPL v4

SPL

SPL Set ID ea39a1c0-6b12-77ba-e053-2995a90a7314

Route

TOPICAL

Published

Effective Date 2024-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (39.2 mg) Octinoxate (25 mg)

Inactive Ingredients

Shorea Robusta Resin Lauroyl Lysine Triethoxycaprylylsilane D&c Red No. 30 Grapefruit Ascorbyl Palmitate Tocopherol .beta.-citronellol, (r)- Mica Titanium Dioxide Carnauba Wax Corn Oil D&c Red No. 7 Ferrosoferric Oxide D&c Red No. 27 Ferric Oxide Red Fd&c Blue No. 1 Aluminum Lake Sweet Cherry Seed Oil Neopentyl Glycol Dicaprylate/dicaprate Caprylyl Glycol Chlorphenesin Water Lecithin, Sunflower High Density Polyethylene Glycerin Rice Bran Oil Olea Europaea (olive) Oil Unsaponifiables Ferric Oxide Yellow Palmitic Acid Talc Helianthus Annuus Seed Wax Disteardimonium Hectorite Cranberry Seed Oil Fd&c Red No. 40 Magnesium Potassium Aluminosilicate Fluoride Rice Bran Phenoxyethanol Apple Seed Oil Toxicodendron Succedaneum Fruit Wax Dipentaerythrityl Hexacaprylate/hexacaprate Tridecyl Trimellitate Toxicodendron Vernicifluum Fruit Rind Wax Polyglyceryl-4 Isostearate Tridecyl Stearate Punica Granatum Seed Oil Hydrogenated Polybutene (1300 Mw) Octyldodecanol Castor Oil Shea Butter Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Hexyl Laurate Fd&c Yellow No. 5 D&c Red No. 21 Aluminum Lake

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-12

Description

Octinoxate 2.50% Zinc Oxide 3.92%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 2.50% Zinc Oxide 3.92%

Uses

Helps prevent sunburn.

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.

Directions

Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.

Do Not Use

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Octinoxate 2.50%

Zinc Oxide 3.92%

Company Information

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

www.cyzone.com

Inactive Ingredients

Octyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, polyethylene, helianthus annuus (sunflower) seed wax, copernicia cerifera (carnauba) wax, glycerin, dipentaerythrityl hexacaprylate/hexacaprate, vegetable oil, oryza sativa (rice) bran oil, tridecyl trimellitate, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, fragrance, tridecyl stearate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, neopentyl glycol dicaprylate/dicaprate, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, lauroyl lysine, hexyl laurate, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, triethoxycaprylylsilane, caprylyl glycol, lecithin, chlorphenesin, water, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol.

May contain:

Mica, titanium dioxide, iron oxides, synthetic fluorphlogopite, red 30 lake, red 7 lake, red 40 lake, talc, red 27 lake, yellow 5 lake, hydrogenated polyisobutene, blue 1 lake, red 21 lake, palmitic acid.

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

Product Packaging Nude Creamy

Product Packaging Pink Creamy

Product Packaging Berry Creamy

Product Packaging Coral Creamy

Product Packaging Cherry Creamy

Product Packaging Fuchsia Creamy

Structured Label Content

Uses

Helps prevent sunburn.

Purpose

Sunscreen

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.

Directions

Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Octinoxate 2.50%

Zinc Oxide 3.92%

Company Information

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

www.cyzone.com

Inactive Ingredients

May contain:

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

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

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

Product Packaging Nude Creamy (Product Packaging - Nude Creamy)

Product Packaging Pink Creamy (Product Packaging - Pink Creamy)

Product Packaging Berry Creamy (Product Packaging - Berry Creamy)

Product Packaging Coral Creamy (Product Packaging - Coral Creamy)

Product Packaging Cherry Creamy (Product Packaging - Cherry Creamy)

Product Packaging Fuchsia Creamy (Product Packaging - Fuchsia Creamy)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "HEXYL LAURATE", "unii": "4CG9F9W01Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 21 ALUMINUM LAKE", "unii": "2M7H5Y5MJP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn.", "Purpose": "Sunscreen", "Warnings": "Skin Cancer / Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only.", "Directions": "Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.", "Do not use": "on damaged or broken skin.", "Other information": "Protect the product in this container from excessive heat and direct sun.", "Active Ingredients": "Octinoxate 2.50% Zinc Oxide 3.92%", "Company Information": "PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia. www.cyzone.com", "Inactive Ingredients": "Octyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, polyethylene, helianthus annuus (sunflower) seed wax, copernicia cerifera (carnauba) wax, glycerin, dipentaerythrityl hexacaprylate/hexacaprate, vegetable oil, oryza sativa (rice) bran oil, tridecyl trimellitate, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, fragrance, tridecyl stearate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, neopentyl glycol dicaprylate/dicaprate, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, lauroyl lysine, hexyl laurate, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, triethoxycaprylylsilane, caprylyl glycol, lecithin, chlorphenesin, water, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol. May contain: Mica, titanium dioxide, iron oxides, synthetic fluorphlogopite, red 30 lake, red 7 lake, red 40 lake, talc, red 27 lake, yellow 5 lake, hydrogenated polyisobutene, blue 1 lake, red 21 lake, palmitic acid.", "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 swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.455899 · Updated: 2026-03-14T23:09:50.407692