Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID edf05ccc-4299-48d5-8f8e-01255eca11c2
Route
TOPICAL
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.4 g) Zinc Oxide (7 g)
Inactive Ingredients
Hydrogenated Polyisobutene (1300 Mw) Phenyl Trimethicone Ethylhexyl Palmitate Dextrin Palmitate (corn; 20000 Mw) Sunflower Oil Medium-chain Triglycerides Glyceryl Monobehenate Disteardimonium Hectorite Dipalmitoyl Hydroxyproline Butylated Hydroxytoluene C10-18 Triglycerides Calcium Sodium Borosilicate Glyceryl Dioleate Menthol Lactic Acid Linoleic Acid Linolenic Acid Octyldodecanol Oleic Acid Palmitic Acid Palmitoyl Tripeptide-1 Hyaluronate Sodium Sorbitan Isostearate Sorbitan Monooleate Stearic Acid Magnesium Potassium Aluminosilicate Fluoride Tetrahexyldecyl Ascorbate Tocopherol .alpha.-tocopherol Acetate Tribehenin Glyceryl Trioleate Fd&c Blue No. 1 Aluminum Lake Ferric Oxide Red D&c Red No. 6 Fd&c Yellow No. 5 Polyhydroxystearic Acid (2300 Mw) Capsicum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-16
Description

Octinoxate 7.4% Zinc Oxide 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.4% Zinc Oxide 7%

Uses
  • helps prevent sunburn.
Section 50565-1

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

Directions
  • apply generously, covering lips completely at least 15 minutes before sun exposure.

Do not apply outside of lip lines.

  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.
  • children under 6 months of age: Ask a doctor.
Questions?

1-888-995-5656

Do Not Use On
  • damaged or broken skin.
Other Information
  • Protect this product from excessive heat and direct sun. Store between 59-86°F.
Active Ingredients

Octinoxate 7.4%

Zinc Oxide 7%

Inactive Ingredients:

Hydrogenated Polyisobutene, Phenyl Trimethicone, Ethylhexyl Palmitate, Dextrin Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glyceryl Behenate, Disteardimonium Hectorite, Dipalmitoyl Hydroxyproline, BHT, C10-18 Triglycerides, Calcium Sodium Borosilicate, Capsicum Annuum Extract (Fruit), Glyceryl Dioleate, Menthol, Lactic Acid, Linoleic Acid, Linolenic Acid, Octyldodecanol, Oleic Acid, Palmitic Acid, Palmitoyl Tripeptide-1, Polyhydroxystearic Acid, Sodium Hyaluronate, Sorbitan Isostearate, Sorbitan Oleate, Stearic Acid, Synthetic Fluorphlogopite, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Tribehenin, Triolein,+/-: Blue 1 Lake (Cl 42090), Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Red 6 (Cl 15850), Yellow 5 Lake (Cl 19140).

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
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.

Principal Display Panel – 5 Ml Carton Label

RODAN + FIELDS

Plumping Lip Oil

SPF 28

Sunscreen

5 mL/0.17 FL. Oz. U.S.

Structured Label Content

Uses
  • helps prevent sunburn.
Section 50565-1 (50565-1)

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

Purpose

Sunscreen

Directions
  • apply generously, covering lips completely at least 15 minutes before sun exposure.

Do not apply outside of lip lines.

  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.
  • children under 6 months of age: Ask a doctor.
Questions?

1-888-995-5656

Do Not Use On (Do not use on)
  • damaged or broken skin.
Other Information
  • Protect this product from excessive heat and direct sun. Store between 59-86°F.
Active Ingredients

Octinoxate 7.4%

Zinc Oxide 7%

Inactive Ingredients: (Inactive ingredients:)

Hydrogenated Polyisobutene, Phenyl Trimethicone, Ethylhexyl Palmitate, Dextrin Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glyceryl Behenate, Disteardimonium Hectorite, Dipalmitoyl Hydroxyproline, BHT, C10-18 Triglycerides, Calcium Sodium Borosilicate, Capsicum Annuum Extract (Fruit), Glyceryl Dioleate, Menthol, Lactic Acid, Linoleic Acid, Linolenic Acid, Octyldodecanol, Oleic Acid, Palmitic Acid, Palmitoyl Tripeptide-1, Polyhydroxystearic Acid, Sodium Hyaluronate, Sorbitan Isostearate, Sorbitan Oleate, Stearic Acid, Synthetic Fluorphlogopite, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Tribehenin, Triolein,+/-: Blue 1 Lake (Cl 42090), Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Red 6 (Cl 15850), Yellow 5 Lake (Cl 19140).

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.
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.

Principal Display Panel – 5 Ml Carton Label (Principal Display Panel – 5 mL Carton Label)

RODAN + FIELDS

Plumping Lip Oil

SPF 28

Sunscreen

5 mL/0.17 FL. Oz. U.S.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:44.517259 · Updated: 2026-03-14T23:05:39.677923