FDA.reportPublic FDA data

SPF30 Daily Moisturizer with Sunscreen

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 00:53:09

Label at a glance#

ProductSPF30 Daily Moisturizer with Sunscreen
Active ingredientZINC OXIDE
Label structure9 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. Sun Protection Measures: 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 inclu...

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 22%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTHER SAFETY INFORMATION

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION 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: 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, sepacially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Dimethicone, Ethylhexylglycerin, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isononyl Isononanoate, Jojoba Oil, Neopentyl Glycol Dicaprate, Niacinamide, Polyacrylamide, Polyisobutylene, Polysorbate 20, Polysorbate 60, Potassium Sorbate, Propanediol, Squalane, Tocopherol, Triethoxycaprylylsilane, Water

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Tube Prinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Principal Display PanelTube Principal Display Panel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130861429000107GTIN-13: 0861429000107
EAN-13: 0861429000107
GTIN-12: 861429000107
UPC-A: 861429000107
GTIN storage (14 digits): 00861429000107		PREP_Moisturizer_TUBE_20161104.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70231-0020-32021-01-29C16284748780-1ba0f9c33-5624-a910-e053-dadaa90a0b85SPF30 Daily Moisturizer

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70231-002070231-0020-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALANEGW89575KF9IACT
ZINC OXIDESOI2LOH54ZACTIB
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
NEOPENTYL GLYCOL DICAPRATE77T908SE82IACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
TOCOPHEROLR0ZB2556P8IACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
ALLANTOIN344S277G0ZIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
PROPANEDIOL5965N8W85TIACT

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
724cd3c9-6bb9-1528-e053-2a91aa0a8e254132a825-a6fc-53f2-e054-00144ff8d46c2018-07-31WarningsExact identifier
spl id: 724cd3c9-6bb9-1528-e053-2a91aa0a8e25
spl set id: 4132a825-a6fc-53f2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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