Sun Protected Lip Balm Spf 30 +

Sun Protected Lip Balm Spf 30 +
SPL v3
SPL
SPL Set ID 21386652-b952-48be-b077-1acecc7f0eb0
Route
TOPICAL
Published
Effective Date 2021-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (280 mg) Zinc Oxide (240 mg)
Inactive Ingredients
Shea Butter Green Tea Leaf Stevia Rebaudiuna Leaf Holy Basil Leaf Alaria Esculenta Olea Europaea Leaf Candelilla Wax Medium-chain Triglycerides Carnauba Wax Cetyl Esters Wax Glyceryl Caprylate Sunflower Oil Mica Tocopherol Polyhydroxystearic Acid (2300 Mw) Starch, Rice Silicon Dioxide Sorbitan Olivate Cocoa Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-10
Description

Drug Facts Active ingredients Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

Medication Information

Warnings and Precautions

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse with water to remove.
  • Keep out of reach of children, If swallowed, get medical help or contact a poison control centre right away.
Indications and Usage

Uses

  • 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.
Description

Drug Facts Active ingredients Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

Section 51727-6

Inactive ingredients

Sun Protected Lip Balm SPF 30 + - Naturally Naked

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea) Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifers (Carnuba) Wax, Cetyl Esters, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter.

Sun Protected Lip Balm SPF 30 + - Cherry Vanilla

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa(Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl esters, Cherry Vanilla Flavor* Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.

*Flavor is certified all natural.

Sun Protected Lip Balm SPF 30 + - Cucumber Mint

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil , Candelilla Cera wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl Esters, Cucumber Mint Flavor* Glyceryl Caprylate, Helianthus Annuus(Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.

*Flavor is certified all natural.

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Drug Facts

Active ingredients

Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

Section 60561-8

Other information

  • This is a personal care item, and should be used by one individual only.
  • Protect this product from excessive heat and direct sun.
  • Do not use if safety seal is broken prior to purchase.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.
Package Label.principal Display Panel

SUN PROTECT LIP BALM NATURALLY NAKED SPF 30 + 0.15 OZ - Label - NDC - 69555-036-01

SUN PROTECT LIP BALM CUCUMBER MINT SPF 30 + 0.15 OZ - Label - NDC - 69555-036-02

SUN PROTECT LIP BALM CHERRY VANILLA SPF 30 + 0.15 OZ - Label - NDC - 69555-036-03

Structured Label Content

Indications and Usage (34067-9)

Uses

  • 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.
Warnings and Precautions (34071-1)

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse with water to remove.
  • Keep out of reach of children, If swallowed, get medical help or contact a poison control centre right away.
Section 51727-6 (51727-6)

Inactive ingredients

Sun Protected Lip Balm SPF 30 + - Naturally Naked

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea) Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifers (Carnuba) Wax, Cetyl Esters, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter.

Sun Protected Lip Balm SPF 30 + - Cherry Vanilla

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa(Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil, Candelilla Cera Wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl esters, Cherry Vanilla Flavor* Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice Starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.

*Flavor is certified all natural.

Sun Protected Lip Balm SPF 30 + - Cucumber Mint

Butyrospermum Parkii (Shea Butter), Camellis Sinensis (Green Tea)Leaf, Ocimum Tinuiflorum (Tulsi) Leaf, Alaria Esculenta (Wakame Seaweed), and Olea Europa (Olive) Leaf Extracts in Cocos Nucifera (Coconut) Oil , Candelilla Cera wax, Caprylic Capric Triglycerides, Copernicia Prunifera (Carnauba) Wax, Cetyl Esters, Cucumber Mint Flavor* Glyceryl Caprylate, Helianthus Annuus(Sunflower) Seed Oil, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Rice starch, Silica, Sorbitan Olivate, Theobroma Cacao(Cocoa) Seed Butter, Stevia Rebaudiana Leaf Extract.

*Flavor is certified all natural.

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

Non Nano Zinc Oxide 6%, Non Nano Titanium Dioxide 7%

Section 60561-8 (60561-8)

Other information

  • This is a personal care item, and should be used by one individual only.
  • Protect this product from excessive heat and direct sun.
  • Do not use if safety seal is broken prior to purchase.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

SUN PROTECT LIP BALM NATURALLY NAKED SPF 30 + 0.15 OZ - Label - NDC - 69555-036-01

SUN PROTECT LIP BALM CUCUMBER MINT SPF 30 + 0.15 OZ - Label - NDC - 69555-036-02

SUN PROTECT LIP BALM CHERRY VANILLA SPF 30 + 0.15 OZ - Label - NDC - 69555-036-03

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:20.090476 · Updated: 2026-03-14T23:06:59.037711