Aquaphor Lip Repair Stick And Sunscreen Stick
FDA Label NDC 10356-130

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 Repair Stick And Sunscreen (NDC 10356-130). 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 - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active ingredients:

Avobenzone 3%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

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

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

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, Ricinus Communis (Castor) Seed Oil, Beeswax, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Hydrogenated Castor OIl, Helianthus Annuus (Sunflower) Seed Wax, Cetearyl Alcohol, Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol.