Active Ingredients:
Zinc Oxide 20%
Clove Hill Acne Safe Mineral Sunscreen Spf 40 Cream
FDA Label NDC 82746-205
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clove Hill Llc for the product Clove Hill Acne Safe Mineral Sunscreen Spf 40 (NDC 82746-205). 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 active ingredients:, purpose:, uses:, warnings:, directions:, sun protection measures:, inactive ingredients:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Sunscreen
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:
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Apply liberally 15 minutes before sun exposure.
Reapply: After 40 minutes of swimming or sweating
Immediately after towel drying • At least every 2 hours
Children under 6 months: 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, especially from 10:00 a.m.-2:00 p.m.
- Wear long-sleeved snirts, pants, hats, and sunglasses
Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Other Information:
Protect this product from excessive heat and direct sun
May stain some fabrics
Principal Display Panel – 115 G Bottle Label
CLOVE HILL
come home to clear skin
acne-safe
mineral sunscreen
spf 40 broad spectrum
water resistant (40 mins)
net wt. 4 oz /115 g
Principal Display Panel – 115 G Bottle Label (Clo0m 0001 01)
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