Glytone Retexturize Body
FDA Label NDC 64760-208

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 for the product Glytone Retexturize Body (NDC 64760-208). 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 warnings, inactive ingredient, indications & usage, otc - active ingredient, dosage & administration, information for patients, package label.principal display panel, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings



Warnings

For external use only

When using this product

  • keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if
    • rash or irritation develops and lasts.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Inactive Ingredients Water (aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclomethicone, Glyceryl Stearate, Glycerin, Ammonium Hydroxide, PEG-150 Stearate, Polyacrylamide, Cetyl Alcohol, Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Cholesterol, Phenozyethanol, Dimethiconol, C13-14 Isoparafin, Methylparaben, Xanthan gum, cetearyl glucoside, disodium EDTA, tocopheryl acetate, laureth-7

Indications & Usage



Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • Provides moderate protection against sunburn.

Otc - Active Ingredient

Active Ingredients                                 Purpose

Octinoxate 7.5%                                       Sunscreen

Octisalate 5.0%                                         Sunscreen

Oxbenzone 3.0%                                       Sunscreen

Dosage & Administration



Directions

  • Apply daily to cleansed body skin or as directed by your physician; avoid face
  • Apply generously before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Information For Patients



Other Information

Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and harmful effects of the sun. This product is ot intended for sunbathing.

Package Label.Principal Display Panel

Label (Bodylotionlabel)

Label (Bodylotionlabel)


Glytone retexturize body lotion

SPF 15

Glycolic complex

250 ml e/ 8.4 fl. oz.

Otc - Purpose

Purpose   sunscreen

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.

* Please review the disclaimer below.