Active Ingredient
Zinc oxide 19.5%
Vanicream Facial Moisturizer Broad Spectrum Spf30 Cream
FDA Label NDC 45334-325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmaceutical Specialties Inc for the product Vanicream Facial Moisturizer Broad Spectrum Spf30 (NDC 45334-325). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
For external use only
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
Inactive Ingredients
purified 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
Package Label.Principal Display Panel
NDC 45334-325-02
DERMATOLOGIST TESTED
VANICREAM™ Facial Moisturizer
BROAD SPECTRUM SPF30
MINERAL 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)
* Please review the disclaimer below.
