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NDC 50518-0203-11 FACE BALM SPF-15 20 g/100mL Details

FACE BALM SPF-15 20 g/100mL

FACE BALM SPF-15 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CUSTOM RESEARCH LABS. The primary component is ZINC OXIDE.

Product Information

NDC	50518-0203
Product ID	50518-203_db655cdc-9bcf-1aa6-e053-2a95a90a7f2e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	FACE BALM SPF-15
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	CUSTOM RESEARCH LABS
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50518-0203-11 (50518020311)

Pricing Information	N/A
NDC Package Code	50518-203-11
Billing NDC	50518020311
Package	118 mL in 1 JAR (50518-203-11)
Marketing Start Date	2021-07-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL db656279-6450-2a8d-e053-2995a90af96d Details

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

INGREDIENTS AND APPEARANCE

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