VANICREAM SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- titanium dioxide and zinc oxide cream

VANICREAM Sunscreen BROAD SPECTRUM SPF 50 PLUS by

Drug Labeling and Warnings

VANICREAM Sunscreen BROAD SPECTRUM SPF 50 PLUS by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients

Titanium dioxide 5%

Zinc oxide 7%

PURPOSE

Purpose

Sunscreen

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:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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 this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients C20-40 alcohols, caprylyl glycol, cetyl PEG/PPG-10/1 dimethicone, cocoglycerides, dicaprylyl carbonate, dimethicone, 1,2 hexanediol, hydrogenated castor oil, hydrogenated polyisobutene, magnesium chloride, octadecene, PEG-30 dipolyhydroxystearate, pentylene glycol, phenyl trimethicone, purified water, silica, silica dimethyl silylate, squalane, stearyl dimethicone, tridecyl salicylate, triethoxycaprylylsilane, ubiquinone (coenzyme Q10)

QUESTIONS

Questions or Comments? 800-325-8232

www.vanicream.com Official Vanicream

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PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in USA

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Vanicream™ Sunscreen SPF 50+ for sensitive skin is free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives.

• Oil-free
• Non-comedogenic (safe for use on face)
• Odorless
• Non-greasy
• No oxybenzone
• PABA-free
• Gluten-free
• Water resistant (80 minutes)

Vanicream™ Sunscreen SPF 50+ is formulated with zinc oxide and titanium dioxide and does not contain sensitizing chemical sunscreens. It is lightweight, easy-to-spread, and quickly absorbed.

Recommended for daily use by the entire family. Ideal for even the most delicate, sensitive skin (see Directions)

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Dermatologist Recommended

When Vanicream™ Sunscreen SPF 50+ is used as directed with other sun protective measures, it helps provide protection from the sun's harmful rays (UVA and UVB) and decreases the risk of skin cancer and skin aging.

Coenzyme Q10 is an antioxidant which helps prevent damage to the skin by neutralizing free radicals produced when skin is exposed to the sun.

For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800-325-8232.

Official Vanicream

for Sensitive Skin

Kid Friendly

PRINCIPAL DISPLAY PANEL

NDC: 45334-356-04

DERMATOLOGIST RECOMMENDED

VANICREAM™

Sunscreen

BROAD SPECTRUM

SPF 50+

NO SENSITIZING CHEMICAL SUNSCREENS

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde, & other preservatives

Net Wt 4 oz ( 113 g)

INGREDIENTS AND APPEARANCE

VANICREAM SUNSCREEN BROAD SPECTRUM SPF 50 PLUS 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-356
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C20-40 ALCOHOLS (MP 79C) (UNII: SBX8KS13SG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
OCTADECENE (UNII: H5ZUQ6V4AK)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SQUALANE (UNII: GW89575KF9)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-356-04	1 in 1 CARTON	03/27/2013	08/31/2021
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 45334-356-02	57 g in 1 TUBE; Type 0: Not a Combination Product	03/27/2013	09/30/2018
3	NDC: 45334-356-07	7 g in 1 TUBE; Type 0: Not a Combination Product	03/27/2013	07/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/27/2013	08/31/2021

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-356) , pack(45334-356)