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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50518-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50518-203-11	118 mL in 1 JAR; Type 0: Not a Combination Product	07/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/06/2021

Labeler - CUSTOM RESEARCH LABS (028611598)

Name	Address	ID/FEI	Business Operations
Establishment
CUSTOM RESEARCH LABS		028611598	manufacture(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