Otc - Active Ingredient
Active ingredients
Petrolatum 31.0%
Avobenzone 3.0%
Octinoxate 6.75%
Octisalate 4.5%
Octocrylene 2.0%
Oxybenzone 5.4%
Aquaphor Lip Protectant And Sunscreen Lotion
FDA Label NDC 10356-111
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 Aquaphor Lip Protectant And Sunscreen (NDC 10356-111). 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 - do not use, otc - when using, otc - stop use, 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 - Purpose
Purpose
Skin Protectant
Sunscreen
Indications & Usage
Uses
•temporarily protects and helps relieve chapped or cracked lips
•helps protect lips from the drying effects of wind and cold weather
•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 - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product avoid contact with eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if irritation 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
Directions
For sunscreen use: •apply liberally 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 C18-38 Alkyl Hydroxystearoyl Stearate, Octyldodecanol, Glycerin, Ricinus
Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Panthenol, Water, Polyglyceryl-3 Diisostearate,
Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Hydrogenated Castor Oil, Beeswax, C20-40 Alkyl
Stearate, Magnesium Sulfate, Magnesium Stearate, BHT.
Otc - Questions
Questions
800-227-4703
Package Label.Principal Display Panel
Aquaphor Lip Protectant + Sunscreen
Repairs and Protects
For severly dry lips
Broad Spectrum SPF 30
Immediately soothes and helps heal severely dry lips
Fragrance free and Paraben free.
Lip protectant / Sunscreen
Aquaphorlipprotectantsunscreenfront (Aquaphorlipprotectantsunscreenfront)
Aquaphorlipprotectantsunscreenback (Aquaphorlipprotectantsunscreenback)
* Please review the disclaimer below.
