Castor & Shea SPF Face Lotion

Castor and Shea SPF Face by

Drug Labeling and Warnings

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

Drug Details [pdf]

CASTOR AND SHEA SPF FACE- homosalate 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 Face Lotion

DRUG FACTS

ACTIVE INGREDIENTS

Homosalate 10%

Octocrylene 8%

Ethylhexyl Salicylate 5%

Avobenzone 3%

PURPOSE

Sunscreen

USES

• Helps Prevent Sunburn. Decreases The Risk Of Skin Cancer And Early Skin Aging Caused By The Sun.

WARNINGS

• Helps 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), Homosalate, Octocrylene, C12-15 Alkyl Benzoate, Ethyl Salicylate, Propanediol, Butyl Methoxydibenzoylmethane, Laminaria Digitata Extract, Hydrogenated Lecithin, Cetyl-PG Hydroxyethyl Palmitamide, Ceramide 1, Ceramide 2, Ceramide 3, Ceramide 4, Ceramide 6 II, Cholesterol, 1,2-Hexanediol, VP/Eicosene Copolymer, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyaceto-phenone, 1,2-Hexanediol, Sodium Stearoyl Glutamate, Fragrance (Parfum), Tocopheryl Acetate, Bisabolol, Cannabis Sativa Seed Oil, Aloe Barbadensis Leaf Extract, Xanthan Gum, Tetrasodium Glutamate Diacetate, Citric Acid

Package Labeling:

CASTOR AND SHEA SPF FACE 
homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74856-141
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DOCOSANOL (UNII: 9G1OE216XY)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROXYETHYL PALMITYL OXYHYDROXYPROPYL PALMITAMIDE (UNII: ISA73Z2140)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 2 (UNII: C04977SRJ5)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 4 (UNII: SF3LP91341)
CERAMIDE AP (UNII: F1X8L2B00J)
CHOLESTEROL (UNII: 97C5T2UQ7J)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74856-141-00	120 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2020	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/30/2020	03/01/2021

Labeler - UI Global Brands LLC (049073416)

Revised: 12/2022

Document Id: f070bc64-686c-67f4-e053-2995a90a54ff

34390-5

Set id: 2feed9b3-2919-4b1a-ba60-a3fdc50b43fb

Version: 5

Effective Time: 20221222