Glytone Body
- Manufacturer
- Genesis Pharmaceutical
- Effective date
- 2012-06-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:47:05
Label at a glance#
ProductGlytone Body
Active ingredientOCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE
Label structure8 sections
Contacts and useful links#
Websitewww.glytone-usa.com
www.glytone-usa.com
www.glytone-usa.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Sunscreen Active Ingredients
Octinoxate 7.50%
Oxybenzone 3.00%
Avobenzone 2.00%
Octocrylene 1.86%
OTC - PURPOSE SECTION
Purpose
Sunscreen
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
INDICATIONS & USAGE SECTION
Uses
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early aging caused by the sun
Skin exfoliant
Skin moisturizer
WARNINGS SECTION
Warnings
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask a doctor if rash occurs
For external use only
Keep out of reach of children
Do not swallow. If swallowed, get medical help or contact Poison Control right away
Children under 6 months: ask a doctor before use.
DOSAGE & ADMINISTRATION SECTION
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am- 2 pm, wear long sleeve shirts, pants, hats and sunglasses.
INACTIVE INGREDIENT SECTION
Ingredients that do not prevent Sunburn (Inactive Ingredients):
Water (aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, PEG-100 Stearate, Glceryl Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEB-150 Stearate, Cetyl Alcohol, Dimethiconol, Cholesterol, Butyrosperum Parkii (Shea) Butter, Polyacrylamide, Phenoxyethanol, Cetearyl Glucoside, C13-14 Isoparaffin, Methylparaben, Xanthan Gum, Disodium ETA, Tocopheryl Acetate, Laureth-7
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Glytone Body
retexturize body lotion
broad spectrum
sunscreen SPF 15
glycolic complex
12 fl. oz/355 ml.
Pierre Fabre
Distributed by: Genesis Pharmaceutical, Inc.
Parsippany, NJ 07054
Made in USA
1-800-459-8663
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64760-408-02 | 2023-05-08 | C162847 | 48780-1 | 97449f38-c56f-f6ea-e053-dbdaa90aa703 | Glytone Body |
| 64760-408-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c56f-f6ea-e053-dbdaa90aa703 | Glytone Body |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| CETEARYL GLUCOSIDE | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| CYCLOMETHICONE 4 | INACTIVE INGREDIENT | CZ227117JE | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DIMETHICONOL (250000 MW) | INACTIVE INGREDIENT | RKI3S914RT | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| GLYCOLIC ACID | INACTIVE INGREDIENT | 0WT12SX38S | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| PEG-150 STEARATE | INACTIVE INGREDIENT | 7BSG7DF10Q | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYACRYLAMIDE (10000 MW) | INACTIVE INGREDIENT | E2KR9C9V2I | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Glytone Body
- Octinoxate, Oxybenzone, Avobenzene, Octocrylene
- OCTINOXATE
- OXYBENZONE
- AVOBENZONE
- OCTOCRYLENE
- WATER
- GLYCOLIC ACID
- ALKYL (C12-15) BENZOATE
- CYCLOMETHICONE 5
- SODIUM HYDROXIDE
- GLYCERIN
- PEG-100 STEARATE
- GLYCERYL MONOSTEARATE
- CETOSTEARYL ALCOHOL
- CYCLOMETHICONE 4
- PEG-150 STEARATE
- CETYL ALCOHOL
- DIMETHICONOL (250000 MW)
- CHOLESTEROL
- SHEA BUTTER
- POLYACRYLAMIDE (10000 MW)
- PHENOXYETHANOL
- CETEARYL GLUCOSIDE
- C13-14 ISOPARAFFIN
- METHYLPARABEN
- XANTHAN GUM
- EDETATE DISODIUM
- .ALPHA.-TOCOPHEROL ACETATE
- LAURETH-7
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64760-408 | 64760-408-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION, CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 6 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / EXTRACORPOREAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAVENOUS | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SOFT TISSUE | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAUDAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INFILTRATION | ADJ PH | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | ELIXIR / ORAL | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LOTION / TOPICAL | 21 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 78.36 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| SHEA BUTTER | SHEA BUTTER | K49155WL9Y | LOTION / TOPICAL | 2340 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATUMOR | ADJ PH | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | CREAM / VAGINAL | 0.3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | PASTE / DENTAL | 0.6 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f99eb27c-bf96-497e-e053-6294a90ab0f6 | 6962fcc7-e63c-4505-9d0c-d37b80ee9294 | 2023-04-18 | Warnings | 6962fcc7-e63c-4505-9d0c-d37b80ee9294 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.