Otc - Active Ingredient
Active ingredients
Avobenzone, 2.1%
Homosalate, 4.0%
Octisalate, 4.0%
Octocrylene, 2.0%
Hydrating Antioxidant Moiturizer
FDA Label NDC 0363-0540
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Hydrating Antioxidant Moiturizer (NDC 0363-0540). 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, warnings and precautions, otc - questions, otc - keep out of reach of children, dosage & administration, 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 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.
Stop use and ask a doctor •if rash occurs.
Warnings And Precautions
WARNINGS: FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE
THOROUGHLY WITH WATER. IF IRRITATION OR RASH OCCURS,
DISCONTINUE USE. KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT POISON
CONTROL CENTER RIGHT AWAY.
Otc - Questions
QUESTIONS OR COMMENTS?
call 1-800-925-4733
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
•apply liberally 5 minutes before sun exposure
•reapply at least every 2 hours
•use water resistant sunscreen if swimming or
sweating.
•children under 6 months of age: ask a doctor.
•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, specially from 10 a.m. - 2 p.m.
•wear long-sleeved shirts, pants, hats and sunglasses.
Storage And Handling
Other information •protect the product in this
container from excessive heat and direct sun.
Inactive Ingredient
Inactive ingredients Water, Dimethicone,
Trisiloxanane, Isononyl Isononanoate, Glycerin, Cetyl Alcohol,
Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,
PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin,
Dimethicone Crosspolymer, Fragrance, Propylene Glycol,
Myrtus Communis Extract, Xanthan Gum, Retinyl Palmitate, Polysorbate 20, Carbomer,
Disodium EDTA, Ascorbic Acid, Sodium Hydroxide, ,BHT, Hyaluronic Acid.
Package Label.Principal Display Panel
Image Description (Waganti Label)
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