Prime Prometics Lip Oil Spf 35 Bright Berry

Prime Prometics Lip Oil Spf 35 Bright Berry
SPL v1
SPL
SPL Set ID 477fde53-d0ac-3b72-e063-6394a90aa779
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 Ci 19140 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, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Sorbitan Isostearate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Red 7 Lake (Cl 15850), Yellow 5 Lake (Cl 19140), Flavor, Menthone Glycerin Acetal, Iron Oxides (Cl 77492), Dehydroacetic Acid, Iron Oxides (Cl 77491), Iron Oxides (Cl 77499), Rosa Canina Seed Oil, Mangifera Indica (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, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Sorbitan Isostearate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Red 7 Lake (Cl 15850), Yellow 5 Lake (Cl 19140), Flavor, Menthone Glycerin Acetal, Iron Oxides (Cl 77492), Dehydroacetic Acid, Iron Oxides (Cl 77491), Iron Oxides (Cl 77499), Rosa Canina Seed Oil, Mangifera Indica (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: 2026-02-15T12:08:04.765368 · Updated: 2026-03-14T23:12:12.345571