VANICREAM FACIAL MOISTURIZER BROAD SPECTRUM SPF30- zinc oxide cream

Vanicream Facial Moisturizer Broad Spectrum SPF30 by

Drug Labeling and Warnings

Vanicream Facial Moisturizer Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc oxide 19.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep 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.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING

Other information

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients water, C12-15 alkyl benzoate, isopentyldiol, squalane, glycerin, coco-caprylate/caprate, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, PEG-100 stearate, polyhydroxystearic acid, cetearyl alcohol, sucrose stearate, ceramide EOP, ceramide NG, ceramide NP, ceramide AS, ceramide AP, carnosine, phytosterols, hydrogenated lecithin, dimethicone, triethoxycaprylylsilane, polyacrylate crosspolymer-11, caprylyl glycol, 1,2-hexanediol

QUESTIONS

Questions or Comments? 1-800-325-8232

PRINCIPAL DISPLAY PANEL

NDC: 45334-325-02

DERMATOLOGIST TESTED

VANICREAM™ Facial Moisturizer

BROAD SPECTRUM SPF 30

ZINC OXIDE SUNSCREEN WITH CERAMIDES

FOR SENSITIVE SKIN

Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers

Non-comedogenic

Gluten-free

Net Wt 2.5 oz (71 g)

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

INGREDIENTS AND APPEARANCE

VANICREAM FACIAL MOISTURIZER BROAD SPECTRUM SPF30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARNOSINE (UNII: 8HO6PVN24W)
SOY STEROL (UNII: PL360EPO9J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE 5 (UNII: 7848GX36YB)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE NG (UNII: C04977SRJ5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
SUCROSE STEARATE (UNII: 274KW0O50M)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE AP (UNII: F1X8L2B00J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-325-02	1 in 1 CARTON	03/15/2022
1		71 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 45334-325-07	7 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2022	11/30/2025
3	NDC: 45334-325-04	4 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/15/2022

Labeler - Pharmaceutical Specialties Inc (076499557)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Specialties Inc		076499557	label(45334-325) , manufacture(45334-325) , pack(45334-325)