Sun Protect Lip Balm Spf 30 Cream
FDA Label NDC 69555-036

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stream2sea, Llc for the product Sun Protect Lip Balm Spf 30 (NDC 69555-036). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, directions, other safety information, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

Active ingredients

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

Otc - Purpose

Purpose
Sunscreen

Indications & 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.

Warnings

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.

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.

Other Safety Information

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.

Inactive Ingredient

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.

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 Naturally Naked (Label)

Sun Protect Lip Balm Naturally Naked (Label)

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

Sun Protect Lip Balm Cucumber Mint (Label)

Sun Protect Lip Balm Cucumber Mint (Label)

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

Sun Protect Lip Balm Cherry Vanilla (Label)

Sun Protect Lip Balm Cherry Vanilla (Label)

* Please review the disclaimer below.