RICH GIRL HAND SPF 25- rich girl hand cream

RICH GIRL HAND SPF 25 by

Drug Labeling and Warnings

RICH GIRL HAND SPF 25 by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCTS, INC., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 2 %
Octinoxate 7.5 %
Octisalate 5 %

PURPOSE

Sunscreen
Sunscreen
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.

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

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 Spectrumvalue 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.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

LABEL

INGREDIENTS AND APPEARANCE

RICH GIRL HAND SPF 25 
rich girl hand cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-420-01	1 in 1 CARTON	05/15/2012
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-420-04	1 in 1 CARTON	05/15/2012
2	NDC: 59735-420-03	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/15/2012

Labeler - MANA PRODUCTS, INC. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-420)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-420)