Prime Prometics Lip Oil Spf 35 Warm Sienna

Prime Prometics Lip Oil Spf 35 Warm Sienna
SPL v1
SPL
SPL Set ID 4780acf7-fd7b-405e-e063-6294a90adfdf
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (13.5 mg)
Inactive Ingredients
Diisostearyl Malate Ci 77491 Caprylic/capric Triglyceride Isostearic Acid Sorbitan Isostearate Sorbitan Olivate Hydrogenated Castor Oil Microcrystalline Wax Mangifera Indica (mango) Seed Butter Hyaluronic Acid Bis-diglyceryl Polyacyladipate-2 Butyloctyl Salicylate Isononyl Isononanoate Vp/hexadecene Copolymer Ci 77499 Silica Dimethyl Silylate Rosa Canina Seed Oil Hydrogenated Polyisobutene (450 Mw) Polyglyceryl-3 Pentaricinoleate Polybutene (1400 Mw) Lecithin, Sunflower Polyhydroxystearic Acid (2300 Mw) Ricinus Communis (castor) Seed Oil Dehydroacetic Acid Tocopherol Menthone Glycerin Acetal Ci 77492 Titanium Dioxide Ci 15850

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01
Description

Active Ingredients Zinc Oxide 13.5%

Medication Information

Warnings and Precautions

WARNINGS

  • For external use only
Description

Active Ingredients Zinc Oxide 13.5%

Uses

Uses

  • Helps prevent sunburn
  • I used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 50565-1

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

Section 50566-9

Stop use and ask doctorif rash occurs

Section 50567-7

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

Section 50570-1
  • Do not useon damaged or broken skin
Section 51727-6

INACTIVE INGREDIENTS:

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, SilicaDimethyl Silylate, Bis-DiglycerylPolyacyladipate-2, SorbitanOlivate, lsononyl lsononanoate, Sorbitanlsostearate, lsostearic Acid, Lecithin, Polyglyceryl-3Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, IronOxides (Cl 77491), TitaniumDioxide (Cl 77891), Iron Oxides (Cl 77492), Flavor, Menthone GlycerinAcetal, Iron Oxides (Cl 77499), Dehydroacetic Acid, Red 7 Lake (Cl 15850), Rosa Canina Seed Oil, Mangifera lndica (Mango) Seed Butter, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, and Tocopherol.

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Zinc Oxide 13.5%

Directions

DIRECTIONS

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months:

Ask doctor.

Other Information

OTHER INFORMATION

Protect Product in this container from excessive heat and direct sun

Structured Label Content

Uses (USES)

Uses

  • Helps prevent sunburn
  • I 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 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 Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctorif rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)
  • Do not useon damaged or broken skin
Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, SilicaDimethyl Silylate, Bis-DiglycerylPolyacyladipate-2, SorbitanOlivate, lsononyl lsononanoate, Sorbitanlsostearate, lsostearic Acid, Lecithin, Polyglyceryl-3Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, IronOxides (Cl 77491), TitaniumDioxide (Cl 77891), Iron Oxides (Cl 77492), Flavor, Menthone GlycerinAcetal, Iron Oxides (Cl 77499), Dehydroacetic Acid, Red 7 Lake (Cl 15850), Rosa Canina Seed Oil, Mangifera lndica (Mango) Seed Butter, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, and Tocopherol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Zinc Oxide 13.5%

Directions (DIRECTIONS)

DIRECTIONS

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months:

Ask doctor.

Other Information (OTHER INFORMATION)

OTHER INFORMATION

Protect Product in this container from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:04.769608 · Updated: 2026-03-14T23:12:12.345571