Otc - Purpose
• 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
Glow Gloss Lip Balm Spf 40 Pink Peppermint Gel
FDA Label NDC 75936-645
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Supergoop! for the product Glow Gloss Lip Balm Spf 40 Pink Peppermint (NDC 75936-645). 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 - purpose, otc - active ingredient, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, 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
Avobenzone 3%, Homosalate 5%, Octisalate 4%, Octocrylene 4.5%
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
• For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Dosage & Administration
• apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
◦ Limit time in the sun, especially from 10 a.m. - 2 p.m.
◦ Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor
Inactive Ingredient
Inactive Ingredients: Hydrogenated Poly(C6-14 Olefin), Ethylene/Propylene/Styrene Copolymer, Butyloctyl Salicylate, C18-38 Alkyl Hydroxystearoyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Synthetic Wax, Flavor,
Triisostearyl Citrate, Octyldodecanol, Tocopherol, Cocos Nucifera (Coconut) Oil, Butyrospermum
Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Stevia Rebaudiana Leaf/Stem
Extract, Portulaca Pilosa Extract, Citric Acid, Bisabolol, Sorbitan Isostearate, Pentaerythrityl
Tetra-di-t-butyl Hydroxyhydrocinnamate, Sucrose Cocoate, Sorbitan Oleate, Palmitoyl
Tripeptide-38, Butylene/Ethylene/Styrene Copolymer, Cetearyl Ethylhexanoate. May Contain: Titanium Dioxide, Red 28 Lake, Iron Oxides, Red 7 Lake, Yellow 5 Lake.
Package Label.Principal Display Panel
Glow Gloss
Pink Peppermint / Strawberry Spritz / Vanilla Soft Serve
SPF 40
Broad Spectrum Sunscreen SPF 40 PA +++
0.5 fl. oz. / 15 mL
* Please review the disclaimer below.
