Indications & Usage
Helps prevent sunburn.
Glytone Daily Body Lotion
FDA Label NDC 84262-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glytone, Llc for the product Glytone Daily Body (NDC 84262-027). 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 indications & usage, dosage & administration, otc - purpose, warnings, inactive ingredient, recent major changes, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Apply Daily Body Lotion once daily or as directed by a doctor at least 15 minutes before sun exposure.
Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
Otc - Purpose
Avobenzone 2% – Sunscreen
Octinoxate 7.5% – Sunscreen
Octocrylene 1.86% – Sunscreen
Oxybenzone 3% – Sunscreen
Warnings
For external use only.
Sunburn alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for one week afterwards.
Do not use:
- on damaged or broken skin.
- as a sunscreen for sunbathing.
When using this product:
- keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if:
- rash occurs.
Keep out of reach of children.
Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Water, Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEG-40 Stearate, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cetearyl Glucoside, Cetyl Alcohol, Cholesterol, Dimethiconol, Disodium EDTA, Laureth-7, Methylparaben, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate, Xanthan Gum.
Recent Major Changes
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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
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