FDA Label for Aquaphor Lip Protectant And Sunscreen

View Indications, Usage & Precautions

Aquaphor Lip Protectant And Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Beiersdorf Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients
Petrolatum 31.0%
Avobenzone 3.0%
Octinoxate 6.75%
Octisalate 4.5%
Octocrylene 2.0%
Oxybenzone 5.4%


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


* Please review the disclaimer below.