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Drug Facts
Protect Spf 30
FDA Label NDC 70693-231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hunter Vaughan, Llc for the product Protect Spf 30 (NDC 70693-231). 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 other, otc - purpose, uses, directions, sun protection measures, warnings, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Zinc Oxide 11.5% | Sunscreen |
| Octisalate 2.5% | Sunscreen |
| Avobenzone 2.0% | Sunscreen |
Uses
Helps prevent sunburn
If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early aging caused by the sun.
Directions
Shake Well
After cleansing and toning, apply generously 15 minutes prior to sun exposure.
Reapply at least every two hours.
Use a water-resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours.
Sun Protection Measures
Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - When Using
When using this product keep out of eyes, Rinse with water to remove
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Water (Aqua), Glyceryl Stearate, Cetearyl Alcohol, Cetyl Alcohol, Caprylic/Capric Triglycerides, Glycerin, Ethyl Macadamiate, Ethoxydiglycol, C12-15 Alkyl Benzoate, Olea Europaea (Olive) Fruit Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Carbomer, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Natural)
Principal Display Panel - 50 Ml Bottle Carton
Burke Williams
H2v
[Protect]
Protect SPF 30
daytime moisturizer
2 fl oz 50 ml
Principal Display Panel (50 ml Bottle Carton)
* Please review the disclaimer below.
