Active Ingredients
Zinc Oxide 8%
Homosalate 6%
Octocrylene 3%
Standard Procedure Lip Balm Spf 50 Stick
FDA Label NDC 84425-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Standard Procedure Inc for the product Standard Procedure Lip Balm Spf 50 (NDC 84425-105). 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 active ingredients, dosage & administration, purpose, uses, warnings, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun
Purpose
Sunscreen
Uses
Helps prevent sunbum
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and earty skin aging caused by the sun
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
Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away
Directions
Apply generously and evenly 15 minutes before sun exposure • reapply at least every 80 minutes • 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, regularty use a sunscreen with broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor
Other Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Ricinus Communis (Castor) Seed Oil, Caprylic/capric Triglyceride, Ozokerite, C12-15 Alkyl| Benzoate, Butyrospermum Parki (Shea) Butter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Tribehenin, Silica Dimethyl Silylate, Polyglyceryl-3 Polyricinoleate, Bis-Ethythexyloxyphenol Methoxypheny! Triazine, Flavor, Triacontanyl Pup,Tocopheryl Acetate, Stevia Rebaudiana Leaf
Package Label. Principal Display Panel
Standard Procedure
Lipbalm SPF 50+
Coconut
Broad Spectrum UVA/UVB
5g 0.17oz.
IMAGE Lip Balm 240410.jpg
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