RICH GIRL HAND- avobenzone, octinoxate, and octisalate cream

Rich Girl by

Drug Labeling and Warnings

Rich Girl by is a Otc medication manufactured, distributed, or labeled by Lippmann Enterprises, LLC, Mana Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone - 2.0%	Sunscreen
Octinoxate - 7.5%	Sunscreen
Octisalate - 5.0%	Sunscreen

Uses

• helps prevent sunburn
• 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.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop and ask a doctor if rash occurs.

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

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

Directions

For sunscreen use:

• 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 this risk, regularly use a sunscreen with a Broad Spectrum value of 15 SPF or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun
• You may report a serious adverse reaction to this product to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

Water, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Octyldodecyl Neopentanoate, Propylene Glycol, Glyceryl Stearate, Dimethicone, PEG-100 Stearate, Glycerin, Steareth-20, Phenoxyethanol, Ceteth-20, Persea Gratissima (Avocado) Oil, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Fragrance, O-Cymen-5-ol, Sodium Hydroxide, Butylene Glycol, Algae Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Morus Nigra Root Extract, Saxifraga Sarmentosa Extract, Scutellaria Baicalensis Root Extract, Vitis Vinifera (Grape) Fruit Extract, Disodium EDTA.

SPL UNCLASSIFIED SECTION

Lippmann Enterprises LLC, DISTR.
New York, NY 10001

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

deborah
lippmann®

rich
Girl™
hand cream

Broad Spectrum
SPF 25 Sunscreen
Hand Cream

Net Wt 3 Oz/85 g

INGREDIENTS AND APPEARANCE

RICH GIRL   HAND
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49991-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARETH-20 (UNII: L0Q8IK9E08)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETETH-20 (UNII: I835H2IHHX)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
MORUS NIGRA ROOT (UNII: 033456LFG1)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
WINE GRAPE (UNII: 3GOV20705G)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49991-001-01	1 in 1 CARTON	05/15/2012
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49991-001-02	940 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2012

Labeler - Lippmann Enterprises, LLC (125251012)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products, Inc		078870292	MANUFACTURE(49991-001)