KARANJA TREE SUNSHIELD SPF 30 MOLTON BROWN SKIN CARE- avobenzone, ensulizole, octinoxate, octocrylene cream

Karanja Tree Sunshield SPF 30 by

Drug Labeling and Warnings

Karanja Tree Sunshield SPF 30 by is a Otc medication manufactured, distributed, or labeled by Molton Brown LTD, DDD Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients  Purpose

Avobenzone 3% Sunscreen

Ensulizole 3%      Sunscreen

Octinoxate 7.5%  Sunscreen

Octocrylene 2%   Sunscreen

Use

Provides high protection against sunburn - For skin highly sensitive to sunburn.

keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

indications

Stop use and ask a doctor if skin rash or irritation occurs.

Warnings

For external use only.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

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

Directions

-Apply generously before sun exposure

-reapply as needed or after towel drying, swimming, or sweating.

Inactive ingredients

 Acrylate/acrylamide copolymer, aluminum starch octenylsuccinate, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl glycol, chlorphenesin, cyclohexasiloxane, cyclopentasiloxane, dimethicone, diethylhexyl carbonate, disodium EDTA, ethylhexyl benzoate, ethyhexyl methoxycrylene,fragrance (parfum), glycerin, glyceryl stearate, hydrogenated coco-glycerides, isohexadecane, Peg-100 stearate, phenyl trimethicone, phenoxyethanol, pongamal, polysorbate 80, potassium sorbate, potassium cetylphosphate, Pueraria Lobata root extract, Sorbitan oleate, sorbic acid, Tocopheryl acetate, triethanolamine, water (aqua).

PRINCIPAL DISPLAY PANEL

Molton Brown Skin Care
Karanja Tree Sunshield SPF30 50ml 1.7 fl oz

INGREDIENTS AND APPEARANCE

KARANJA TREE SUNSHIELD SPF 30  MOLTON BROWN SKIN CARE
avobenzone, ensulizole, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68814-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBIC ACID (UNII: X045WJ989B)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68814-128-02	1 in 1 BOX
1	NDC: 68814-128-01	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/30/2010

Labeler - Molton Brown LTD (769334822)

Registrant - Molton Brown LTD (769334822)

Establishment
Name	Address	ID/FEI	Business Operations
DDD Ltd.		216339804	manufacture(68814-128)