RE-FLECT- titanium dioxide, zinc oxide cream

Re-Flect by

Drug Labeling and Warnings

Re-Flect by is a Otc medication manufactured, distributed, or labeled by Goldeneye Permanent System GmbH Germany. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide .30 percent

Zinc Oxide .30 percent

INACTIVE INGREDIENT

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.

DO NOT USE

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.

PURPOSE

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.

STOP USE

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

WARNINGS

For External Use Only

DOSAGE & ADMINISTRATION

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.

QUESTIONS

Call: (201) 917- 5858

STORAGE AND HANDLING

Store at Room Temperature

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RE-FLECT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.28 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.28 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
KARUM SEED OIL (UNII: 62160PU6FJ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
AMILOXATE (UNII: 376KTP06K8)
BEMOTRIZINOL (UNII: PWZ1720CBH)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
FARNESOL (UNII: EB41QIU6JL)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-119-01	1 in 1 CARTON	01/01/2019
1		50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2019

Labeler - Goldeneye Permanent System GmbH Germany (329178144)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System GmbH Germany		329178144	label(71056-119) , manufacture(71056-119)