FDA Label for Glytone Retexturize Body

View Indications, Usage & Precautions

Glytone Retexturize Body Product Label

The following document was submitted to the FDA by the labeler of this product Glytone. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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.