FACE BALM SPF-15- avobenzone, homosalate, octisalate, octocrylene lotion 
CUSTOM RESEARCH LABS

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.

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CRL (as CMO) - FACE BALM SPF-15 (50518-203)

ACTIVE INGREDIENTS

AVOBENZONE (3.0%)

HOMOSALATE (5.0%)

OCTISALATE (3.0%)

OCTOCRYLENE (3.0%)

PURPOSE

SUNSCREEN

USES

Apply to cleansed skin, gently smoothing over the face and neck. For best results, follow the complete Urth Skin Solutions regimen. Appliquer sur une peau nettoyee en lissant delicatement le visage et le cou. Pour de meilleurs resultats, suivez le regime complet d'Urth Skin Solutions.

CAUTION/ ATTENTION

For external use only. Avoid eye contact. Store in cool, dry area. Pour usage externe suelement. Eviter le contact des yeaus. Conserver dans un endroit frais et sec.

INACTIVE INGREDIENTS

Water (Aqua), Propylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Carthamus Tinctorus (Safflower) Seed Oil, Stearic Acid, Cetyl Alcohol, Ethylhexyl Glycerin, Xanthan Gum, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Sodium Hydroxide, Sodium Hyaluronate, Niacinamide, Camellia Sinensis (White Tea) Leaf Extract, Ascorbic Acid (Vit. C), Tocopheryl Acetate (Vit.E), Aloe Barbadensis Leaf Extract, Panex Ginseng Extract, Salix Alba (Willow) Bark Extract, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Avena Sativa (Oat) Kernel Flour, Phenoxyethanol.

FACE BALM SPF-15

01b_LBL_Face Balm SPF 15_4oz.jpg

FACE BALM SPF-15 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
COCONUT OIL (UNII: Q9L0O73W7L)  
LANOLIN (UNII: 7EV65EAW6H)  
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SOYBEAN OIL (UNII: 241ATL177A)  
GERANIOL (UNII: L837108USY)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUGENOL (UNII: 3T8H1794QW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50518-203-11118 mL in 1 JAR; Type 0: Not a Combination Product07/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/06/2021
Labeler - CUSTOM RESEARCH LABS (028611598)
Establishment
NameAddressID/FEIBusiness Operations
CUSTOM RESEARCH LABS028611598manufacture(50518-203)

Revised: 3/2022
Document Id: db655cdc-9bcf-1aa6-e053-2a95a90a7f2e
Set id: db656279-6450-2a8d-e053-2995a90af96d
Version: 1
Effective Time: 20220329
 
CUSTOM RESEARCH LABS