Castor & Shea SPF Body Lotion

Castor and Shea SPF Body by

Drug Labeling and Warnings

Castor and Shea SPF Body by is a Otc medication manufactured, distributed, or labeled by UI Global Brands LLC, Xiamen Triz Laboratories Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CASTOR AND SHEA SPF BODY- homosalate, octocrylene, octisalate, octinoxate, avobenzone cream 
UI Global Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Castor & Shea SPF Body Lotion

DRUG FACTS

ACTIVE INGREDIENTS

Homosalate 10%

Octocrylene 8%

Ethylhexyl Salicylate 5%

Ethylhexyl Methoxycinnamate 5%

Avobenzone 3%

PURPOSE

Sunscreen

USES

• Helps prevent sunburn. 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 Reach Out Of Eyes. Rinse With Water To Remove.

Stop Use And Ask A Doctor 

If Rash Occurs.

Keep Out Of Reach Of Children.

If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.

DIRECTIONS

• For Sunscreen Use. Apply Generously And Evenly 15 Minutes Before Sun Exposure. Reapply As Needed At Least Every 2 Hours.

INACTIVE INGREDIENTS

• Water (Aqua), Propanediol, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethanol, Sodium Stearoyl Glutamatem, Fragrance, Caprylyl Glycol, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis Leaf Extract, Cannabis Sativa Seed Oil, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea Butter), Xanthan Gum, Tetrasodium Glutamate Diacetate, Citric Acid, Retinyl Palmitate (Vitamin A).

Package Labeling:

CASTOR AND SHEA SPF BODY 
homosalate, octocrylene, octisalate, octinoxate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74856-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74856-040-00	180 mL in 1 TUBE; Type 0: Not a Combination Product	06/20/2020	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/20/2020	03/08/2021

Labeler - UI Global Brands LLC (049073416)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Triz Laboratories Ltd.		421290822	manufacture(74856-040)

Revised: 12/2022

Document Id: f047c7dd-a0a3-6a4c-e053-2a95a90a522d

34390-5

Set id: edb1e97d-5a7b-4785-ad47-58839ca5491a

Version: 3

Effective Time: 20221220