Re-Flect

Manufacturer
Goldeneye Permanent System GmbH Germany
Effective date
2019-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:57:44

Label at a glance#

ProductRe-Flect
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Storage and handling

Store at Room Temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide .30 percent

Zinc Oxide .30 percent

INACTIVE INGREDIENT SECTION

AQUA, ISOAMYL P-METHOXYCINNAMATE, DICAPRYLYL CARBONATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, GLYCERIN, C14-22 ALCOHOLS, PONGAMIA GLABRA SEED OIL, HELIANTHUS ANNUUS SEED OIL, SODIUM STEAROYL GLUTAMATE, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, PARFUM, TOCOPHEROL, HYDROGENATED PALM GLYCERIDES CITRATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POLYGLYCERYL-3 POLYRICINOLEATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, INULIN LAURYL CARBAMATE, BUTYLENE GLYCOL, C12-20 ALKYL GLUCOSIDE, JOJOBA ESTERS, STEARIC ACID, TRIHYDROXYSTEARIN, POLYHYDROXYSTEARIC ACID, SILICA, BENZYL ALCOHOL, CINNAMYL ALCOHOL, CITRONELLOL, FARNESOL, HYDROXYCITRONELLAL, LIMONENE, LINALOOL.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

- Avoid around the eye area or any sensitive areas of the skin

- If product gets into the eye, rinse eyes thoroughly with water.

OTC - PURPOSE SECTION

Uses

Helps Prevent Sunburn and keeps skin moisturized. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

OTC - STOP USE SECTION

Stop Use and see a dermatologist if you notice redness that lasts, swelling after application, itching or rashes that lasts.

WARNINGS SECTION

For External Use Only

DOSAGE & ADMINISTRATION SECTION

Apply generously and atleast 20 minutes before sun exposure.

Children under 6 months of age: Ask a doctor

For Sunscreen use to be applied to all skin exposed to the sun.

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, especially during peak sun exposure times.

- wear long sleeved shirts, pants, hats and sunglasses.

OTC - QUESTIONS SECTION

Call: (201) 917- 5858

STORAGE AND HANDLING SECTION

Store at Room Temperature

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bdr sunscreenbdr sunscreen

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71056-119-012021-03-08C16284748780-1ba0f9c33-15ae-a910-e053-dadaa90a0b8596b0a0bf-453d-a650-e053-2a95a90a128c
71056-119-012021-01-29C16284748780-1ba0f9c33-15ae-a910-e053-dadaa90a0b8596b0a0bf-453d-a650-e053-2a95a90a128c

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71056-11971056-119-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
c342c353-fe22-5e21-e053-2995a90ad8b096b0a0bf-453d-a650-e053-2a95a90a128c2021-05-26WarningsExact identifier
spl set id: 96b0a0bf-453d-a650-e053-2a95a90a128c

Reported adverse events (FAERS/openFDA)#

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