VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate and zinc oxide cream

VANICREAM Sunscreen BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

VANICREAM Sunscreen BROAD SPECTRUM SPF 35 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

Octinoxate 2.8%
Zinc Oxide 11%

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, cetyl PEG/PPG-10/1 dimethicone, cyclohexasiloxane, cyclopentasiloxane, cyclotetrasiloxane, dimethiconol, glycerin, hydrogenated castor oil, magnesium chloride, PEG-30 dipolyhydroxystearate, polypropyl silsesquioxane, purified water, tridecyl neopentanoate, triethoxycaprylylsilane, trimethylsiloxy silicate, ubiquinone (coenzyme Q10)

QUESTIONS

Questions or Comments? 800-325-8232
www.vanicream.com Official Vanicream

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PHARMACEUTlCAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in USA

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Vanicream™ Sunscreen Sport SPF 35 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)

Formulated with zinc oxide and octinoxate, Vanicream™ Sunscreen Sport SPF 35 is lightweight, easy-to-spread, quickly absorbed, and transparent.

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

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Dermatologist Tested

When Vanicream™ Sunscreen Sport SPF 35 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.

Contains Coenzyme Q10.

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: 45334-355-04

DERMATOLOGIST TESTED

VANICREAM™

Sunscreen Sport

BROAD SPECTRUM

SPF 35

FOR SENSITIVE SKIN

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 35 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.028 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.11 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C20-40 ALCOHOLS (MP 79C) (UNII: SBX8KS13SG)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)
WATER (UNII: 059QF0KO0R)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
UBIDECARENONE (UNII: EJ27X76M46)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-355-04	1 in 1 CARTON	04/18/2013
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 45334-355-02	57 g in 1 TUBE; Type 0: Not a Combination Product	04/18/2013	03/31/2019
3	NDC: 45334-355-07	7 g in 1 TUBE; Type 0: Not a Combination Product	04/18/2013	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/18/2013

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-355) , pack(45334-355)