FDA.reportPublic FDA data

PREP SPF 15 Lip Gloss

Manufacturer
PREP Cosmetics LLC | Richard Hamer Associates LLC | Taka USA Inc. dba Cosmetic Innovations
Effective date
2018-07-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:53:08

Label at a glance#

ProductPREP SPF 15 Lip Gloss
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

Apply generously 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When Using

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply generously 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Children under 6 months: ask a doctor

Sun Protection Measures

OTHER SAFETY INFORMATION

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 am- 2 pm
  • wear long-sleeved shirts, pants, hats. and sunglasses

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Back carton labelBack carton labelCastor Oil, Coconut Oil, Diisostearyl Malate, Ethylhexylglycerin, Ferric Oxide Red, Isostearic Acid, Jojoba Oil, Potassium Sorbate, Propanediol, Spearmint Oil, Succinic Acid, Tocopherol, Triethoxycaprylylsilane, Yellow Wax

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelCarton label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130861429000121GTIN-13: 0861429000121
EAN-13: 0861429000121
GTIN-12: 861429000121
UPC-A: 861429000121
GTIN storage (14 digits): 00861429000121		PREP SPF 15 Lip Gloss Carton December 2014.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70231-0012-72021-01-29C16284748780-1ba0f9c33-2d57-a910-e053-dadaa90a0b85PREP SPF 15 Lip Gloss

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70231-001270231-0012-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
YELLOW WAX2ZA36H0S2VIACT
CASTOR OILD5340Y2I9GIACT
ISOSTEARIC ACIDX33R8U0062IACT
SUCCINIC ACIDAB6MNQ6J6LIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SPEARMINT OILC3M81465G5IACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIB
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
724d0889-5b86-3125-e053-2a91aa0a92c1237fad3c-532b-3a1f-e054-00144ff8d46c2018-07-31WarningsExact identifier
spl id: 724d0889-5b86-3125-e053-2a91aa0a92c1
spl set id: 237fad3c-532b-3a1f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.