Otc - Active Ingredient
Active ingredients:
Avobenzone 2.5
Octocrylene 7%
Nivea Smoothness Lip Care Stick
FDA Label NDC 10356-819
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beiersdorf Inc for the product Nivea Smoothness Lip Care (NDC 10356-819). 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, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away
Dosage & Administration
For sunscreen use
- apply liberally at least 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every two hours
- 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 SpectrumSPFvalue 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
Octyldodecanol, Hydrogenated Rapeseed
Oil, Beeswax, Cetyl Palmitate, Ricinus Communis (Castor) Seed Oil,
Polyglyceryl-3 Diisostearate, Butyrospermum Parkii (Shea) Butter,
Glycerin,Water, Simmondsia Chinensis (Jojoba) Seed Oil, Persea
Gratissima (Avocado) Oil, Aloe Barbadensis Leaf Juice, Flavor, BHT
Otc - Questions
Questions? 1-800-227-4703
Package Label.Principal Display Panel
Smoothnesscardhi (Smoothnesslipcardhi)
Smoothness
Lip Care
and Sunscreen
broad spectrum SPF 15
All Day Nourishing Moisture
Mineral Oil Free
* Please review the disclaimer below.
