C Lip Serum Mineral Broad Spectrum Spf 30 Gel
FDA Label NDC 83302-165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Simply Active Cosmetics for the product C Lip Serum Mineral Broad Spectrum Spf 30 (NDC 83302-165). 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, warnings, instructions for use, inactive ingredient, indications & usage, dosage & administration, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Instructions For Use

→ Inactive Ingredient

→ Indications & Usage

→ Dosage & Administration

→ Otc - Keep Out Of Reach Of Children

→ Package Label.principal Display Panel

Otc - Active Ingredient

Zinc Oxide 16.5% … Sunscreen

Otc - Purpose

Sunscreen

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.

Stop use and ask a doctor if rash occurs

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

Instructions For Use

Apply lip serum generously and evenly
Reapply at least every 2 hours throughout the day as needed
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

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 your time in the sun, especially from 10 a.m. to 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredient

Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, C12-15 Alkyl Benzoate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Poly(C6-14 Olefin), Mica, Glyceryl Dibehenate, Flavor, Microcrystalline Cellulose, Tribehenin, Polyglyceryl-3 Diisostearate, Microcrystalline Wax, Cellulose Gum, Synthetic Fluorphlogopite, Glyceryl Behenate, Lecithin, Caprylyl Glycol, Sodium Chloride, Citric Acid, Ethylhexylglycerin, Polyglyceryl-4 Oleate, Sodium Citrate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Limonene, Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850)

Indications & Usage

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.

Dosage & Administration

Apply lip serum generously and evenly

Apply liberally 15 minutes before sun exposure

Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Children under 6 months of age: Ask a doctor

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.

Package Label.Principal Display Panel

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Drug Facts

0.35 FL. OZ. 10 g NDC: 83302-165-11

Outer Carton Front Panel

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Side Panel 1

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Side Panel 2

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Drug Facts Cont Side Panel 1