NDC | 45334-355-02, 45334-355-04, 45334-355-07 |
Set ID | 8a4db0fc-d5b4-4eb0-8fa5-bb8cdacdb232 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmaceutical Specialties, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
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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
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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
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
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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SPL UNCLASSIFIED SECTION
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
-
INGREDIENTS AND APPEARANCE
VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35
octinoxate and zinc oxide creamProduct 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 09/30/2022 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 09/30/2022 Labeler - Pharmaceutical Specialties, Inc. (076499557) Establishment Name Address ID/FEI Business Operations Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-355) , pack(45334-355)